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SRPS EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)

Jun 19, 2008
95.99   Withdrawal of Standard   Aug 29, 2011

General information

95.99     Aug 29, 2011

ISS

Z076

European Norm

11.120.01     11.040.01     11.080     11.100.20  

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Scope

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Directive 90/385/EEC
93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 10993-7:2008
95.99 Withdrawal of Standard
Aug 29, 2011

REVISED BY

PUBLISHED
SRPS EN ISO 10993-7:2011

Related project

Adopted from EN ISO 10993-7:1995

Adopted from ISO 10993-7:1995 IDENTICAL