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BS EN 556:1995

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
Available format(s)

Hardcopy , PDF

Superseded date

12-11-2001

Language(s)

English

Published date

03-15-1995

Publisher

British Standards Institution

Cooperating organizations
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. Requirements
Annex
A. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Specifies the requirements for a terminally sterilized medical device to be labelled 'STERILE'. Also gives definitions.

Committee
CH/198
DevelopmentNote
DRAFT FOR COMMENT 91/57782 DC
DocumentType
Standard
Pages
12
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NS EN 556 : 94 AMD 1 98 Identical
EN 556:1994 + A1:1998 Identical
UNI EN 556 : 2000 Identical
NF EN 556 : 95 AMD 1 98 Identical
NBN EN 556 : 95 AMD 1 98 Identical
UNE-EN 556:1999 Identical
SN EN 556 : 1999 Identical
NEN EN 556 : 95 AMD 1 98 Identical
I.S. EN 556:1994 Identical
DIN EN 556:1999-01 Identical

BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
BS EN 1617:1997 Sterile drainage catheters and accessory devices for single use

EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002

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Hardcopy - English
PDF - English
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