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MEDICAL DEVICES: General (EU DIR 93/42/EEC) Collection

Description:
MEDICAL DEVICES: General (EU DIR 93/42/EEC) Collection contains more than 280 documents.

On June 14, 1998, the European Union Medical Devices Directive became mandatory for all manufacturers selling medical devices in the European marketplace. The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI-scanners. Companies manufacturing Class I Sterile, Class I Measuring, IIa, IIb or Class III devices that fall within the scope of the Medical Devices Directive must meet the essential requirements of that law.

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Popular Standards from this Collection.

BSI BS EN 1041

Information Supplied by the Manufacturer with Medical Devices

BSI BS EN 1060- 1

Non-invasive sphygmomanometers - Part 1: General requirements-AMD 13881: October 8, 2002; Supersedes BS 2743: 1990

BSI BS EN 1060- 2

Non-Invasive Sphygmomanometers - Part 2: Supplementary Requirements for Mechanical Sphygmomanometers-CORR 14063: December 19, 2002; Together with BS EN 1060-1 Supersedes BS 2743:1990;

BSI BS EN 1060- 3

Non-Invasive Sphygmomanometers Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measuring Systems

BSI BS EN 1060- 4

Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

BSI BS EN 1089- 3

Transportable gas cylinders Gas cylinder identification (excluding LPG) Part 3: Colour coding-Supersedes BS 349: 1973 and BS 349C: 1973

BSI BS EN 1174- 1

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 1: Requirements

BSI BS EN 1174- 2

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 2: Guidance

BSI BS EN 1174- 3

Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 3: Guide to the Methods for Validation of Microbiological Techniques

BSI BS EN 12006- 1

Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 1: Heart Valve Substitutes

BSI BS EN 12006- 2

Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 2: Vascular Prostheses Including Cardiac Valve Conduits

BSI BS EN 12006- 3

Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 3: Endovascular Devices

BSI BS EN 12010

Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements

BSI BS EN 12011

Instrumentation to be Used in Association with Non-Active Surgical Implants - General Requirements

BSI BS EN 12180

Non-Active Surgical Implants - Body Contouring Implants - Specific Requirements for Mammary Implants

BSI BS EN 12182

Technical Aids for Disabled Persons - General Requirements and Test Methods

BSI BS EN 12183

Corr.1 Manually Propelled Wheelchairs - Requirements and Test Methods-CORR 10712; September 1999

BSI BS EN 12184

Corr.1 Electrically Powered Wheelchairs, Scooters and Their Chargers - Requirements and Test Methods-CORR 10713; September 1999

BSI BS EN 12218

Rail systems for supporting medical equipment-AMD 13723: October 16, 2002;

BSI BS EN 12322

In Vitro Diagnostic Medical Devices - Culture Media for Microbiology - Performance Criteria for Culture Media-AMD 13482: December 24, 2001

BSI BS EN 12342

Corr.1 Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators-CORR 10395; December 15, 1998; Supersedes BS 6151: 1992

BSI BS EN 12442- 1

Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1: Analysis and Management of Risk

BSI BS EN 12442- 2

Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection and Handling

BSI BS EN 12442- 3

Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents

BSI BS EN 12470- 1

Clinical Thermometers - Part 1: Metallic Liquid-In-Glass Thermometers with Maximum Device

BSI BS EN 12470- 2

Clinical Thermometers - Part 2: Phase Change Type (Dot Matrix) Thermometers

BSI BS EN 12470- 3

Clinical Thermometers - Part 3: Performance of Compact Electrical Thermometers (Non-Predictive and Predictive) with Maximum Device

BSI BS EN 12470- 4

Clinical Thermometers - Part 4: Performance of Electrical Thermometers for Continuous Measurement

BSI BS EN 12470- 5

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

BSI BS EN 12523

External limb prostheses and external orthoses . Requirements and test methods-CORR 14082: February 21, 2003; Supersedes BS 2574-3:1990

BSI BS EN 12563

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip Joint Replacement Implants

BSI BS EN 12564

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants

BSI BS EN 12598

Oxygen monitors for patient breathing mixtures Particular requirements-Supersedes BS 5724-2.24:1997; Superseded by BS EN ISO 21647:2004; Also known as BS 5724-2.27:1999

BSI BS EN 1280- 1

Agent Specific Filling Systems for Anaesthetic Vaporizers - Part 1: Rectangular Keyed Filling Systems-AMD 11039: January 2001

BSI BS EN 1281- 2

Anaesthetic and Respiratory Equipment - Conical Connectors Part 2: Screw-Threaded, Weight-Bearing Connectors (N)

BSI BS EN 1282- 1

Anaesthetic and Respiratory Equipment - Tracheostomy Tubes Part 1: Tubes for Use in Adults-Supersedes BS 6149: Part 1: 1987; Superseded by BS EN ISO 5366- 1:2004

BSI BS EN 1282- 2

Tracheostomy Tubes Part 2: Paediatric Tubes

BSI BS EN 13014

Connections for gas sampling tubes to anaesthetic and respiratory equipment-CORR 14062: December 16, 2002;

BSI BS EN 13220

Flow-Metering Devices for Connection to Terminal Units of Medical Gas Pipeline Systems

BSI BS EN 13221

High-Pressure Flexible Connections for Use with Medical Gases

BSI BS EN 13328- 1

Breathing System Filters for Anaesthetic and Respiratory Use - Part 1: Salt Test Method to Assess Filtration Performance

BSI BS EN 13328- 2

Breathing system filters for anaesthetic and respiratory use Part 2: Non- filtration aspects-CORR 14268: December 18, 2002; AMD 14946: February 4, 2004

BSI BS EN 13503- 8

Ophthalmic Implants - Intraocular Lenses - Part 8: Fundamental Requirements

BSI BS EN 13544- 1

Respiratory therapy equipment Part 1: Nebulizing systems and their components-AMD 15265:July 26, 2004; Supersedes BS 7711-3:1994

BSI BS EN 13544- 2

Respiratory Therapy Equipment - Part 2: Tubing and Connectors- Supersedes BS 7711-1:1994;

BSI BS EN 13544- 3

Respiratory Therapy Equipment - Part 3: Air Entrainment Devices- Supersedes BS 7711-2:1994;

BSI BS EN 13624

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1)

BSI BS EN 13718- 1

Air, Water and Difficult Terrain Ambulances Part 1: Medical Devices Interface Requirements for the Continuity of Patient Care

BSI BS EN 13718- 2

Air, Water and Difficult Terrain Ambulances Part 2: Operational and Technical Requirements for the Continuity of Patient Care

BSI BS EN 13726- 1

Test Methods for Primary Wound Dressings - Part 1: Aspects of Absorbency

BSI BS EN 13726- 2

Test Methods for Primary Wound Dressings - Part 2: Moisture Vapour Transmission Rate of Permeable Film Dressings

BSI BS EN 13726- 3

Non-active medical devices Test methods for primary wound dressings Part 3: Waterproofness

BSI BS EN 13726- 4

Non-active medical devices Test methods for primary wound dressings Part 4: Conformability

BSI BS EN 13726- 6

Non-active medical devices Test methods for primary wound dressings Part 6: Odour control

BSI BS EN 13727

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1)

BSI BS EN 13795- 1

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Part 1: General requirements for manufacturers, processors and products

BSI BS EN 13795- 2

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment Part 2: Test methods

BSI BS EN 13824

Sterilization of medical devices Aseptic processing of liquid medical devices Requirements

BSI BS EN 13826

Peak expiratory flow meters

BSI BS EN 13867

Concentrates for haemodialysis and related therapies

BSI BS EN 13976- 1

Rescue systems Transportation of incubators Part 1: Interface conditions

BSI BS EN 14079

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

BSI BS EN 14180

Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing

BSI BS EN 1422

Sterilizers for medical purposes Ethylene oxide sterilizers Requirements and test methods-CORR 14232: February 25, 2003; Partially Supersedes BS 3970-1: 1990;

BSI BS EN 14299

Non active surgical implants Particular requirements for cardiac and vascular implants Specific requirements for arterial stents

BSI BS EN 14348

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants Test methods and requirements (phase 2, step 1)

BSI BS EN 1441

Medical Devices - Risk Analysis-Superseded by BS EN ISO 14971

BSI BS EN 1618

Catheters Other than Intravascular Catheters - Test Methods for Common Properties

BSI BS EN 1639

Dentistry Medical devices for dentistry Instruments

BSI BS EN 1640

Dentistry Medical devices for dentistry Equipment

BSI BS EN 1641

Dentistry Medical devices for dentistry Materials

BSI BS EN 1642

Dentistry Medical devices for dentistry Dental implants

BSI BS EN 1707

Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Lock Fittings-Supersedes BS 3930: Part 2:1991;

BSI BS EN 1782

Corr.1 Tracheal Tubes and Connectors-CORR 10173; September 15, 1998; Supersedes BS 3487-1:1989,BS 3487-2:1993,BS 3487-3:1986,BS 3487-5:1986,and BS 6546:1994;

BSI BS EN 1789

Medical Vehicles and Their Equipment - Road Ambulances-AMD 14479: June 27, 2003;

BSI BS EN 1819

Laryngoscopes for Tracheal Intubation - Particular Requirements- Superseded by BS EN ISO 7376: 2003; Supersedes BS 6578: Part 1: 1985 and BS 6578: Part 2: 1985

BSI BS EN 1820

Anaesthetic Reservoir Bags-Supersedes BS 3353: 1987;

BSI BS EN 1865

Specifications for Stretchers and Other Patient Handling Equipment Used in Road Ambulances-CORR 15987: September 27, 2005

BSI BS EN 1970

Adjustable Beds for Disabled Persons - Requirements and Test Methods

BSI BS EN 1985

Walking Aids - General Requirements and Test Methods-Partially Supersedes BS 4997: 1991, BS 5181: 1975 and BS 5205: 1990

BSI BS EN 20594- 1

Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 1: General Requirements-AMD 9881: March 15, 1998; ISO 594- 1: 1986; Supersedes BS 3930: 1965 and BS 5081: 1976;

BSI BS EN 27740

Instruments for Surgery, Scalpels with Detachable Blades, Fitting Dimensions-AMD 9907: March 15, 1998; ISO 7440: 1985; Supersedes BS 2982: 1986

BSI BS EN 285

Sterilization - Steam Sterilizers - Large Sterilizers-Supersedes BS 3970: Part 3: 1990 and the Current Provisions of BS 3970: Part 1: 1990, Which is Subject to Amendment;

BSI BS EN 30993- 3

Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (ISO 10993-3: 1992) (N)-Superseded by BS EN ISO 10993-3: 2003

BSI BS EN 30993- 4

Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood-ISO 10993-4: 1992; Replaces BS 5736: Part 11: 1989; Superseded by BS EN ISO 10993-4: 2002;

BSI BS EN 30993- 5

Biological Evaluation of Medical Devices Part 5: Tests for Cytotoxicity, in Vitro Methods-Superseded by BS EN ISO 10993-5: 1999;

BSI BS EN 30993- 6

Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation (ISO 10993-6: 1994) (N)

BSI BS EN 375

Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Professional Use

BSI BS EN 376

Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing

BSI BS EN 455- 1

Medical Gloves for Single Use - Part 1: Requirements and Testing for Freedom from Holes

BSI BS EN 455- 2

Medical Gloves for Single Use - Part 2: Requirements and Testing for Physical Properties

BSI BS EN 455- 3

Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation-Together with BS EN 455-1 and -2, Supersedes BS 4005: 1996;

BSI BS EN 46003

Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9003

BSI BS EN 475

Medical Devices - Electrically-Generated Alarm Signals-Supersedes BS 7618: Part 1: 1992; Superseded by BS EN 60601-1-8:2004

BSI BS EN 540

Clinical Investigation of Medical Devices for Human Subjects-AMD 8162: March 15, 1994;

BSI BS EN 550

Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization

BSI BS EN 552

Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation-AMD 10623: September 1999; AMD 13085: June 2001

BSI BS EN 554

Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat

BSI BS EN 556

Sterilization of Medical Devices - Requirements for Terminally- Sterilized Devices to Be Labelled ´Sterile´-Superseded by BS EN 556-1:2001

BSI BS EN 556- 1

Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices

BSI BS EN 556- 2

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices

BSI BS EN 591

Instructions for Use for In Vitro Diagnostic Instruments for Professional Use

BSI BS EN 592

Instructions for Use for in Vitro Diagnostic Instruments for Self- Testing

BSI BS EN 600

Natural Rubber Latex Male Condoms-Supersedes BS 3704:1989; Also Known as BS 3704:1996

BSI BS EN 60118- 13

Electroacoustics Hearing aids Part 13: Electromagnetic compatibility (EMC)

BSI BS EN 60522

Determination of the Permanent Filtration of X-Ray Tube Assemblies- IEC 60522: 1999;

BSI BS EN 60580

Dose Area Product Meters-IEC 60580:2000;

BSI BS EN 60601- 1

Medical Electrical Equipment Part 1: General Requirements for Safety- AMD 6715: December 1990; AMD 7940: November 1995; AMD 9693: October 1997; Renumbers BS 5724: Part 1: 1989

BSI BS EN 60601-1- 1

Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard - Safety Requirements for Medical Electrical Systems-Also Known as BS 5724-1-1: 2001

BSI BS EN 60601-1- 2

Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests-IEC 60601-1-2: 2001

BSI BS EN 60601-1- 3

Medical Electrical Equipment Part 1: General Requirements for Safety Section 1.3: Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment-Also Known as BS 5724: Section 1.3; IEC 601-1-3: 1994

BSI BS EN 60601-1- 4

Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems-AMD 13000: April 2001; Also Known as BS 5724-1.4:1997; IEC 60601-1-4:1996

BSI BS EN 60601-1- 6

Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: Usability

BSI BS EN 60601-1- 8

Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

BSI BS EN 60601-2- 1

Medical electrical equipment Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV-AMD 14465: August 5, 2003; Supersedes BS 5724-2-1: 1989 and BS 5724-2-1-1: Supplement No. 1: 1991; Also Known as BS 5724-2

BSI BS EN 60601-2- 10

Medical electrical equipment - Part 2.10: Particular requirements for the safety of nerve and muscle stimulators-AMD 14260: March 21, 2003; Renumbers BS 5724- 2.10: 1988;

BSI BS EN 60601-2- 11

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Section 2.11: Specification for Gamma Beam Therapy Equipment-AMD 15391: October 28,2004; Supersedes BS 5724: Section 2.11: 1989, BS 5724: Section 2.11: Supplement 1: 1989 and BS 572

BSI BS EN 60601-2- 16

Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment-CORR 10991: March 2001; Supersedes BS 5724-2-16: 1989; Also Known as BS 5724-2-16: 1998; IEC 60601-2-16: 1998

BSI BS EN 60601-2- 17

Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

BSI BS EN 60601-2- 18

Medical electrical equipment Part 2: Particular requirements for safety Section 2.18 Specification for endoscopic equipment-AMD 13100: October 31, 2002; Also known as BS 5724-2.18: 1997; IEC 60601-2-18: 1996

BSI BS EN 60601-2- 19

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Baby Incubators-Supersedes BS 5724 Section 2.119:1991; Also Known as BS 5724-2.119:1997; IEC 601-2-19: 1990

BSI BS EN 60601-2- 2

Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

BSI BS EN 60601-2- 20

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Transport Incubators-Supersedes BS 5724 Section 2.120: 1991; Also Known as BS 5724-2.120: 1997; IEC 601-2-20: 1990

BSI BS EN 60601-2- 21

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Infant Radiant Warmers-Also Known as BS 5724: Section 2.121: 1997; IEC 601-2-21: 1995

BSI BS EN 60601-2- 22

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2. 122: Specification for Diagnostic and Therapeutic Laser Equipment-Also Known as BS 5724-2.122:1996; Supersedes BS 5724-2.122:1993; IEC 601-2-22:1995

BSI BS EN 60601-2- 23

Medical Electrical Equipment - Part 2-23: Particular Requirements for the Safety, Including Essential Performance, of Transcutaneous Partial Pressure Monitoring Equipment-Supersedes BS EN 60601-3-1:1997

BSI BS EN 60601-2- 24

Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infusion Pumps and Controllers-CORR 10114: July 1998; Also Known as BS 5724-2- 124:1998; IEC 60601-2-24:1998

BSI BS EN 60601-2- 25

Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs-AMD 9112: July, 1996; AMD 10844: October, 2000; IEC 60601- 2-25: 1993

BSI BS EN 60601-2- 26

Medical electrical equipment Part 2-26: Particular requirements for the safety - Specification for electroencephalographs

BSI BS EN 60601-2- 27

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Electrocardiographic Monitoring Equipment-Also Known as BS 5724: Section 2.127:1995; IEC 601-2-27:1994

BSI BS EN 60601-2- 28

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.128: Specification for X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis-Also Known as BS 5724: Section 2.128: 1993; IEC 601-2-28: 1993

BSI BS EN 60601-2- 29

Medical Electrical Equipment - Part 2-29: Particular Requirements for the Safety of Radiotherapy Simulators-Also Known as BS 5724-2-129: 1999; IEC 60601-2-29: 1999

BSI BS EN 60601-2- 3

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.3: Specification for Short-Wave Therapy Equipment-AMD 10420: April 1999; AMD 7879: August 15, 1993; Renumbers BS 5724-2.3:1992; IEC 60601-2-3:1991

BSI BS EN 60601-2- 30

Medical Electrical Equipment - Part 2-29: Particular Requirements for Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment-IEC 60601-2-30: 1999

BSI BS EN 60601-2- 31

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.31: Specification for External Cardiac Pacemakers with Internal Power Source-AMD 10132: November 1998; Also Known as BS 5724-2.31: 1995; IEC 60601-2-31: 1994

BSI BS EN 60601-2- 32

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.32: Specification for Associated Equipment of X-Ray Equipment-Also Known as BS 5724-2.32:1995; IEC 601-2-32: 1994

BSI BS EN 60601-2- 33

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

BSI BS EN 60601-2- 34

Medical Electrical Equipment - Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment- IEC 60601-2-34: 2000;

BSI BS EN 60601-2- 35

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.35: Specification for Blankets, Pads and Mattresses Intended for Heating in Medical Use-Also Known as BS 5724: Section 2.35: 1997; IEC 601-2-35: 1996

BSI BS EN 60601-2- 36

Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Equipment for Extra-Corporeally Induced Lithotripsy-Also Known as BS 5724- 2-36:1997; IEC 60601-2-36: 1997

BSI BS EN 60601-2- 37

Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment-IEC 60601-2-37: 2001;

BSI BS EN 60601-2- 38

Medical Electrical Equipment - Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds-AMD 10992:October 2000; CORR 13017: December 2000; Also Known as BS 5724-2.38:1997; IEC 60601-2-38: 1996

BSI BS EN 60601-2- 39

Medical Electrical Equipment - Part 2-39: Particular Requirements for Safety - Specification for Peritoneal Dialysis Equipment-CORR 1 10990: June 2001; Supersedes BS EN 50072: 1992; IEC 60601-2-39: 1999; Also Known as BS 5724-2.39: 1999

BSI BS EN 60601-2- 4

Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators-Supersedes BS 5724-2.4: 1985;

BSI BS EN 60601-2- 40

Medical Electrical Equipment - Part 2-40: Particular Requirements for Safety - Specification for Electromyographs and Evoked Response Equipment-Also Numbered as BS 5724-2.40: 1998; IEC 60601-2-40: 1998;

BSI BS EN 60601-2- 41

Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires FOR Diagnosis-IEC 60601-2-41:2000;

BSI BS EN 60601-2- 43

Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-Ray Equipment for Interventional Procedures-IEC 60601-2-43:2000;

BSI BS EN 60601-2- 44

Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography-AMD 14238: February 19, 2003; Also Known as BS 5724-2.44: 2001;

BSI BS EN 60601-2- 45

Medical Electrical Equipment - Part 2-45: Particular Requirements for Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices-Also Known as BS 5724-2-45:2001; IEC 60601-2-45:2001

BSI BS EN 60601-2- 46

Medical Electrical Equipment - Part 2: Particular Requirements for Safety - Specification for Operating Tables-Supersedes BS 5724-2.22: 1987; Also Known as BS 5724-2.46: 1998; IEC 60601-2-46: 1998;

BSI BS EN 60601-2- 47

Medical Electrical Equipment - Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems-IEC 60601-2-47:2001;

BSI BS EN 60601-2- 49

Medical Electrical Equipment - Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment-IEC 60601-2-49:2001;

BSI BS EN 60601-2- 5

Medical Electrical Equipment - Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment-Supersedes BS 5724-2-5: 1985;

BSI BS EN 60601-2- 50

Medical Electrical Equipment - Part 2-50: Particular Requirements for the Safety of Infant Phototherapy Equipment-IEC 60601-2-50: 2000;

BSI BS EN 60601-2- 51

Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

BSI BS EN 60601-2- 7

Medical Electrical Equipment - Part 2-7: Particular Requirements for Safety - Specification for High Voltage Generators of Diagnostic X-Ray Generators-Supersedes BS 5724-2.7: 1987; Also Known as BS 5724-2.7: 1998; IEC 60601-2-7: 1998;

BSI BS EN 60601-2- 8

Medical Electrical Equipment - Part 2: Particular Requirements for Safety Section 2.8 Specification for Therapeutic X-Ray Equipment Operating in the Range 10 kV to 1 MV-CORR 10098: November 1998; Supersedes BS 5724-2.8:1987; Also Known as BS 5724- 2.8:1998

BSI BS EN 60601-2- 9

Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.9: Specification for Patient Contact Dosemeters Used in Radiotherapy with Electrically Connected Radiation Detectors-Supersedes BS 5724: Section 2.9:1988; Also Known as BS 5

BSI BS EN 60627

Diagnostic X-ray imaging equipment Characteristics of general purpose and mammographic anti-scatter grids-CORR 14056: October 23, 2002; IEC 60627: 2001; Supersedes BS 5913: 1980;

BSI BS EN 60645- 1

Electroacoustics - Audiological Equipment - Part 1: Pure-Tone Audiometers-IEC 60645-1:2001

BSI BS EN 60645- 2

Audiometers Part 2: Equipment for Speech Audiometry-IEC 60645-2: 1993

BSI BS EN 60645- 3

Audiometers Part 3: Auditory Test Signals of Short Duration for Audiometric and Neuro-Otological Purposes-IEC 645-3: 1994

BSI BS EN 60645- 4

Audiometers Part 4: Equipment for Extended High-Frequency Audiometry- IEC 645-4: 1994

BSI BS EN 61217

Radiotherapy Equipment - Coordinates, Movements and Scales-AMD 13331:February 15, 2002; IEC 61217: 1996;

BSI BS EN 61223-3- 1

Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Tests - Imaging Performance of X-Ray Equipment for Radiographic and Radioscopic Systems-IEC 61223-3-1: 1999;

BSI BS EN 61223-3- 4

Evaluation and Routine Testing in Medical Imaging Departments Part 3-4: Acceptance Tests - Imaging Performances of Dental X-Ray Equipment-IEC 61223-3-4: 2000;

BSI BS EN 61223-3- 5

Evaluation and routine testing in medical imaging departments Part 3-5: Acceptance tests Imaging performance of computed tomography X-ray equipment

BSI BS EN 61676

Medical electrical equipment Dosimetric instruments used for non- invasive measurement of X-ray tube voltage in diagnostic radiology

BSI BS EN 62083

Medical Electrical Equipment - Requirements for the Safety of Radiotherapy Treatment Planning Systems-CORR 13355:September 2001; IEC 62083:2000;

BSI BS EN 62220- 1

Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1: Determination of the detective quantum efficiency

BSI BS EN 724

Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for Non-Active Medical Devices (N)

BSI BS EN 737- 1

Medical Gas Pipeline Systems - Part 1: Terminal Units for Compressed Medical Gases and Vacuum-Together with BS EN 739: 1998, it Partially Supersedes BS 5682: 1984:

BSI BS EN 737- 2

Medical Gas Pipeline Systems - Part 2: Anaesthetic Gas Scavenging Disposal Systems - Basic Requirements-AMD 10864, August 2000; Together with BS EN 737- 4: 1998 and Clause 111 of BS EN 740: 1998, it Supersedes BS 6834: 1987;

BSI BS EN 737- 3

Medical Gas Pipeline Systems - Part 3: Pipelines for Compressed Medical Gases and Vacuum

BSI BS EN 737- 4

Medical Gas Pipeline Systems Part 4: Terminal Units for Anaesthetic Gas Scavenging Systems-Together with BS EN 737-2: 1998 and Clause 111 of BS EN 740: 1998, it Supersedes BS 6834: 1987, Which will be Withdrawn in Due Course;

BSI BS EN 738- 1

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices-AMD 13720: October 16, 2002;

BSI BS EN 738- 2

Pressure Regulators for Use with Medical Gases Part 2: Manifold and Line Pressure Regulators-Corr 1; 10802 Corr.No.1, March 2000

BSI BS EN 738- 3

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves-AMD 13721: October 16, 2002;

BSI BS EN 738- 4

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment-AMD 13719: October 16, 2002;

BSI BS EN 739

Low-pressure hose assemblies for use with medical gases-AMD 13722: October 16, 2002; Together with BS EN 737-1: 1998, it Partially Supersedes BS 5682: 1984;

BSI BS EN 740

Anaesthetic workstations and their modules Particular requirements- AMD 15021:July 7, 2004; Supersedes BS 5724-13:1990; Together with BS EN 737-2:1998 and BS EN 737-4:1998 partially supersedes BS 6834:1997; Also known as BS 5724- 2.204:1999

BSI BS EN 793

Particular Requirements for Safety of Medical Supply Units-Superseded by BS EN ISO 11197:2004

BSI BS EN 794- 1

Lung Ventilators - Part 1: Particular Requirements for Critical Care Ventilators-AMD 13084: July 2001; Supersedes BS 5724-2.12: 1990; Also Known as BS 5724- 2.202: 1997

BSI BS EN 794- 2

Lung Ventilators Part 2: Particular Requirements for Home Care Use- Superseded by BS EN ISO 10651-2:2004; Also Known as BS 5724: Section 2.203: 1997

BSI BS EN 794- 3

Lung Ventilators - Part 3: Particular Requirements for Emergency and Transport Ventilators

BSI BS EN 864

Medical Electrical Equipment - Capnometers for Use with Humans - Particular Requirements-Also Known as BS 5724: Section 2.30: 1997; Superseded by BS EN ISO 21647:2004

BSI BS EN 865

Pulse Oximeters - Particular Requirements-Superseded by BS EN ISO 9919:2005; Also Known as BS 5724: Section 2.201: 1997

BSI BS EN 867- 1

Non-Biological Systems for Use in Sterilizers Part 1: General Requirements-:2006

BSI BS EN 867- 2

Non-Biological Systems for Use in Sterilizers Part 2: Process Indicators (Class A)-:2006

BSI BS EN 867- 3

Non-Biological Systems for Use in Sterilizers Part 3: Specification for Class B Indicators for Use in the Bowie and Dick Test-CORR 10589: January 2000

BSI BS EN 867- 4

Non-Biological Systems for Use in Sterilizers - Part 4: Specification for Indicators as an Alternative to the Bowie and Dick Test for the Detection of Steam Penetration- Supersedes BS 7720:1995

BSI BS EN 867- 5

Non-Biological Systems for Use in Sterilizers - Part 5: Specification for Indicator Systems and Process Challenge Devices for Use in Performance Testing for Small Sterilizers Type B and Type S

BSI BS EN 868- 1

Packaging Materials and Systems for Medical Devices Which are to be Sterilized Part 1: General Requirements and Test Methods

BSI BS EN 980

Graphical Symbols for Use in the Labelling of Medical Devices

BSI BS EN ISO 10079- 1

Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment - Safety Requirements-Also known as BS 5724-2.28:2000

BSI BS EN ISO 10079- 2

Medical Suction Equipment - Part 2: Manually Powered Suction Equipment

BSI BS EN ISO 10079- 3

Medical Suction Equipment - Part 3: Suction Equipment Powered from a Vacuum or Pressure Source

BSI BS EN ISO 10535

Hoists for the Transfer of Disabled Persons - Requirements and Test Methods

BSI BS EN ISO 10555- 1

Sterile, Single-Use Intravascular Catheters Part 1: General Requirements- AMD 10805; January 2000; Supersedes BS 7174-1:1990;

BSI BS EN ISO 10651- 2

Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients- Supersedes BS EN 794-2:1997

BSI BS EN ISO 10651- 4

Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators-Partially Supersedes BS 6850: 1987;

BSI BS EN ISO 10651- 6

Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices

BSI BS EN ISO 10993- 1

Biological evaluation of medical devices Part 1: Evaluation and testing

BSI BS EN ISO 10993- 10

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity-CORR 14275: December 20, 2002;

BSI BS EN ISO 10993- 11

Biological Evaluation of Medical Devices Part 11: Tests for Systematic Toxicity (N)

BSI BS EN ISO 10993- 12

Biological evaluation of medical devices Part 12: Sample preparation and reference materials

BSI BS EN ISO 10993- 13

Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices

BSI BS EN ISO 10993- 14

Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics-CORR 13748: March 15, 2002

BSI BS EN ISO 10993- 15

Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys

BSI BS EN ISO 10993- 16

Biological Evaluation of Medical Devices Part 16: Toxicokinetic Study Design for Degradation Products and Leachables

BSI BS EN ISO 10993- 17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

BSI BS EN ISO 10993- 2

Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements

BSI BS EN ISO 10993- 3

Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-CORR 14920: December 23, 2003; Supersedes BS EN 30993-3: 1994;

BSI BS EN ISO 10993- 4

Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood-CORR 14295: January 29, 2003; Supersedes BS EN 30993-4: 1994;

BSI BS EN ISO 10993- 5

Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity-Supersedes BS EN 30993-5:1994;

BSI BS EN ISO 10993- 7

Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals (N)

BSI BS EN ISO 10993- 8

Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests

BSI BS EN ISO 10993- 9

Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products-AMD 10742: January 2000;

BSI BS EN ISO 11196

Anaesthetic Gas Monitors-Superseded by BS EN ISO 21647:2004

BSI BS EN ISO 11197

Medical supply units-Supersedes BS EN 793:1998

BSI BS EN ISO 11810

Optics and optical instruments - Lasers and laser-related equipment - Test method for the laser-resistance of surgical drapes and/or patient-protective covers-CORR 14227: October 29, 2002; Superseded by BS EN ISO 11810-1:2005

BSI BS EN ISO 11810- 1

Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration-Supersedes BS EN ISO 11810:2002

BSI BS EN ISO 11990

Cor 1 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts-CORR 14594: July 22, 2003

BSI BS EN ISO 12870

Ophthalmic optics Spectacle frames Requirements and test methods-Supersedes BS EN ISO 12870:1998 and BS EN ISO 9456:1997

BSI BS EN ISO 13485

Medical devices Quality management systems Requirements for regulatory purposes

BSI BS EN ISO 13488

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002-Supersedes BS EN 46002: 1997; ISO 13488: 1996

BSI BS EN ISO 14155- 1

Clinical investigation of medical devices for human subjects Part 1: General requirements-CORR 14481: May 15, 2003; Supersedes BS EN 540: 1993;

BSI BS EN ISO 14155- 2

Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

BSI BS EN ISO 14160

Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants

BSI BS EN ISO 14534

Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Fundamental Requirements-CORR 14036: August 14, 2002;

BSI BS EN ISO 14602

Non-Active Surgical Implants - Implants for Osteosynthesis - Particular Requirements

BSI BS EN ISO 14630

Non-active surgical implants General requirements

BSI BS EN ISO 14889

Ophthalmic optics Spectacle lenses Fundamental requirements for uncut finished lenses-CORR 14633; August 19, 2003;

BSI BS EN ISO 14937

Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices-CORR 13353:September 2001; CORR 15195:June 16, 2004

BSI BS EN ISO 14971

Medical Devices - Application of Risk Management to Medical Devices-CORR 14652; August 19, 2003

BSI BS EN ISO 15001

Anaesthetic and respiratory equipment Compatibility with oxygen- AMD 15145:June 24, 2004; Renumbers BS ISO 15001:2003

BSI BS EN ISO 15004

Ophthalmic Instruments - Fundamental Requirements and Test Methods

BSI BS EN ISO 17510- 1

Sleep Apnoea Breathing Therapy - Part 1: Sleep Apnoea Breathing Therapy Devices

BSI BS EN ISO 17510- 2

Sleep apnoea breathing therapy Part 2: Masks and application accessories

BSI BS EN ISO 17664

Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

BSI BS EN ISO 18778

Respiratory equipment Infant monitors Particular requirements

BSI BS EN ISO 18779

Medical devices for conserving oxygen and oxygen mixtures Particular requirements

BSI BS EN ISO 21647

Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors-Supersedes BS EN 12598:1999, BS EN 864:1997 and BS EN ISO 11196:1997

BSI BS EN ISO 22612

Clothing for protection against infectious agents Test method for resistance to dry microbial penetration

BSI BS EN ISO 4074

Natural latex rubber condoms Requirements and test methods-CORR 13919:May 13, 2002; CORR 15435:February 22, 2005; Supersedes BS EN 600:1996

BSI BS EN ISO 4135

Anaesthetic and Respiratory Equipment - Vocabulary

BSI BS EN ISO 5356- 1

Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets

BSI BS EN ISO 5366- 1

Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults-Supersedes BS EN 1282-1:1997

BSI BS EN ISO 7376

Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation-CORR 15163: May 6, 2004; Supersedes BS EN 1819:1998

BSI BS EN ISO 7439

Copper-Bearing Intra-Uterine Contraceptive Devices - Requirements, Tests

BSI BS EN ISO 8185

Humidifiers for medical use General requirements for humidification systems-CORR 14088: February 19, 2003; Supersedes BS 5724-2-24: 1989; Also Known as BS 5724-2-24: 1998

BSI BS EN ISO 8359

Medical Electrical Equipment - Oxygen Concentrators for Medical Use - Safety Requirements-Supersedes BS 5724: Section 2.23: 1989; Also Known as BS 5724- 2.23: 1997

BSI BS EN ISO 8835- 4

Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices

BSI BS EN ISO 8835- 5

Inhalational anaesthesia systems Part 5: Anaesthesia ventilators-CORR 15541:March 7, 2005

BSI BS EN ISO 9360- 1

Anaesthetic and Respiratory Equipment - Heat and Moisture Exchangers (HMEs) for Humidifying Respired Gases in Humans - Part 1: HMEs for Use with Minimum Tidal Volumes of 250 ml

BSI BS EN ISO 9360- 2

Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml

BSI BS EN ISO 9703- 3

Anaesthetic and Respiratory Care Alarm Signals - Part 3: Guidance on Application of Alarms

BSI BS EN ISO 9713

Neurosurgical implants Self-closing intracranial aneurysm clips- Supersedes BS 6788-3:1990

BSI BS EN ISO 9919

Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use-Supersedes BS EN 865:1997

BSI DD CEN/TS 14507- 1

Inhalational nitric oxide systems Part 1: Delivery systems

BSI DD CEN/TS 14507- 2

Inhalational nitric oxide systems Part 2: Supply systems

BSI DD ENV 12718

Medical Compression Hosiery

BSI DD ENV 12719

Medical Thrombosis Prophylaxis Hosiery

BSI DD ENV 737- 6

Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum

BSI PD CR 13825

Luer Connectors - a Report to CEN CHeF from the CEN Forum Task Group "Luer Fittings"

BSI PD CR 13903

General Guidance on the Equipment Used for Inhaled Nitric Oxide Therapy

CEN PREN 13795- 3

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements

CEN PREN 14561

Chemical Disinfectants - Quantitative Carrier Test for Evaluation of Bactericidal Activity of Chemical Disinfectants for Instruments Used in Medical Area - Test Method and Requirements (Phase 2/Step 2)

CEN PREN 14562

Chemical disinfectants - Quantitative carrier test for evaluation of fungicidal activity of chemical disinfectants for instruments used in medical area - Test method and requirements (phase 2/step 2)

CEN PREN 14563

Chemical Disinfectants - Quantitative Carrier Test for Evaluation of Mycobactericidal Activity of Chemical Disinfectants for Instruments Used in Medical Area - Test Method and Requirements (Phase 2/Step 2)

CEN PREN 14683

Surgical masks - Requirements and test methods

CEN PREN 14931

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

CEN PREN 285

Sterilization - Steam sterilizers - Large sterilizers

CEN PREN ISO 10083

Oxygen concentrator supply systems for use with medical gas pipeline systems-ISO/DIS 10083:2004

CEN PREN ISO 14408

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information-ISO/DIS 14408:2003

CEN PREN ISO 15883- 1

Washer-Disinfectors - Part 1: General Requirements, Definitions and Tests-ISO/DIS 15883-1:1999

CEN PREN ISO 15883- 2

Washer-disinfectors - Part 2: Requirements and tests for washer- disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, hollowware, utensils, glassware, etc.-ISO/DIS 15883-2: 2003

CEN PREN ISO 15883- 3

Washer-Disinfectors - Part 3: Requirements and Tests for Washer- Disinfectors for Human Waste-Containers-ISO/DIS 15883-3:1999

CENELEC PREN 50323

General Requirements for Hearing Aids

EU 93/42/EEC

Commission Communication in the Framework of the Implementation of Council Directive in Relation to Medical Devices (1)-98/C 144/02; Text with EEA Relevance

EU 93/42/EEC

Council Directive Concerning Medical Devices-for Related Standards See TEST/93/42 : 1996

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