Consolidated

NS-EN 556:1994+A1:1998

Oct 1998 Withdrawn

Corrigenda and amendments are bought separately.

Language English

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Abstract

1.1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled "STERILE". NOTE: For the purpose of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device "STERILE" is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices.

Document information

Consolidated from SN
Published: 7 October 1998
Withdrawn: 10 January 2002
Edition: 2
Version: 1
Document type: NAT
ISBN:

ICS 11.080
ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 98/79/EC, 93/42/EEC

Product Relations

Replaced by: NS-EN 556-1:2001
Merges: NS-EN 556:1994

Product life cycle

Current product

Withdrawn

NS-EN 556:1994+A1:1998
Replaced by

Withdrawn

NS-EN 556-1:2001

NS-EN 556:1994+A1:1998

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