BS EN 556-2:2003

Sterilization of medical devices. Requirements for medical devices to be designated

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BS EN 556-2:2003 specifies the requirements for an aseptically processed medical deviceto be designated STERILE.

NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is STERILE is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).

Cross References:
90/385/EEC
93/42/EEC
98/79/EC
EN 556-1
EN 980
prEN 13824
EN ISO 9001:2000
ISO 9001:2000
EN ISO 13488
ISO 13488:1996
EN ISO 14160:1998
ISO 14160:1998
EN ISO 14937:2000
ISO 14937:2000
EN ISO14971
ISO 14971:2000
European Pharmacopoeia 4
EN 550
EN 552
EN 554
EN ISO 13485
ISO 13485:2003

Keywords: Medical equipment; Medical instruments; Sterile equipment; Sterilization (hygiene); Quality control; Controlled-atmosphere rooms; Environment (working); Microorganisms; Particulate materials; Contaminants; Contamination

Product Code(s): 30055793,30055793

This product references:BS EN ISO 9001:2000 - Quality management systems. Requirements
BS EN ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants
ISO 14937:2000 - 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
ISO 9001:2000 - Quality management systems -- Requirements
ISO 13488:1996 - Quality systems - Medical devices - Particular requirements for the application of ISO 9002
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants

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