Personal reflectors - Requirements

Personal reflectors - Testing

Code of Practice for fume cupboards

Profiles for medical image interchange

A method for defining profiles for healthcare

Medical informatics - Methodology for the development of healthcare messages

Supporting document to ENV 1613:1994 - Messages for Exchange of Laboratory Information

Medical Data Interchange: Mapping between the models specified in ENV 12539:1997 og NEMA PS3 Supplement 10

Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale

Health Informatics - Safety and Security Related Software Quality Standards for Healthcare (SSQS)

Endotracheal tubes

General guidance on the equipment used for inhaled nitric oxide therapy

Health informatics - Interoperability of healthcare multimedia report systems

Health informatics - Framework for security protection of healthcare communication

Health informatics - Framework for security requirements for intermittently connected devices

Laboratory biorisk management standard

Laboratory biorisk management

Cleanrooms and associated controlled environments – Part 3: Test methods

Sterilization - Steam sterilizers - Large sterilizers

Wall hung W.C. pan with close coupled cistern - Connecting dimensions

Wall hung W.C. pan with independent water supply - Connecting dimensions

Suction catheters for use in the respiratory tract

Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements

Anaesthetic reservoir bags

Tracheal tubes and connectors

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for professional use

In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing

In vitro diagnostic medical devices - Measurements of quantities in samples of biological origin - Presentation of reference measurement procedures

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials

Technical aids for disabled persons - Classification

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

Anaesthetic workstations and their modules - Particular requirements

Pressure regulators for use with medical gases. Part 1: Pressure regulators and pressure regulators with flow metering devices

Injection containers for injectables and accessories - Part 1: Injection vials made of glass tubing

Injection containers for injectables and accessories - Part 2: Closures for injection vials

Injection containers for injectables and accessories - Part 3: Aluminium caps for injection vials

Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass

Aluminum caps for transfusion, infusion and injection bottles - General requirements and test methods

Wall-hung hand rinse basins - Connecting dimensions

Biological evaluation of medical devices - Part 1: Guidance on selection of tests

Instruments for surgery - Scalpels with detachable blades - Fitting dimensions

Medical gloves for single use - Part 2: Requirements and testing for physical properties

Clinical investigation of medical devices for human subject

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

Sterilization of medical devices - Validation and routine control of sterilization by moist heat

In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professionel use

In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home use

Quality systems - Medical devices - Particular requirements for the application of EN 29002

Natural rubber latex male condoms

Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods

Guidance on the application of EN 29001 and 46001 and of EN 29002 and EN 46002 for non-active medical devices

Kitchen sinks - Connecting dimensions

In-vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements, tests

Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements

Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers

Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers

Non-biological systems for use in sterilizers - Part 1: General requirements

Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum

Low-pressure hose assemblies for use with medical gases

Particular requirements for safety of medical supply units

Lung ventilators - Part 1: Particular requirements for critical care ventilators

Medical electrical equipment - Capnometers for use with humans - Particular requirements

Pulse oximeters - Particular requirements

Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

WC pans with integral trap

Graphical symbols for use in the labelling of medical devices