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Standard

EN 556-1, Publication date: 2001-10

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Standard

EN 60601-1, Publication date: 1990-08

Medical electrical equipment; part 1: general requirements for safety (IEC 60601-1:1988)

Standard

EN ISO 4287, Publication date: 1998-08

Geometrical product specification (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters (ISO 4287:1997)

Standard

EN ISO 5356-1, Publication date: 2004-05

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)

Standard

EN 980, Publication date: 2008-05

Symbols for use in the labelling of medical devices

Standard

ISO 11607, Publication date: 2003-02

Packaging for terminally sterilized medical devices

Standard

ISO 7000, Publication date: 2004-01

Graphical symbols for use on equipment - Index and synopsis

Standard

EN ISO 4135, Publication date: 2001-08

Anaesthetic and respiratory equipment  - Vocabulary (ISO 4135:2001)

Standard

EN 1041, Publication date: 2008-08

Information supplied by the manufacturer of medical devices

Administrative provision

93/42/EWG, Publication date: 1993-06-14

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

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