Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

ONORM EN ISO 10993-7 : 2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
Superseded date

13-10-2022

Published date

12-01-2013

Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.3.1 Permanent contact devices
4.3.2 Prolonged exposure devices
4.3.3 Limited exposure devices
4.3.4 Special situations
4.4 Determination of EO and ECH residuals
4.4.1 Safety considerations
4.4.2 Determination of residue
4.4.3 Product sampling
4.4.4 Sample/fluid ratios
4.4.5 Extraction time and conditions
4.4.6 Product extraction
4.4.7 Data analysis and interpretation
5 Product release
5.1 Release of products without dissipation curve
        data
5.2 Procedure for product release using residue
        dissipation curves
Annexes
A Evaluation of gas chromatograms
B Gas chromatographic determination for EO and ECH
C Factors influencing product residuals
D Extraction conditions for determination of
        residual EO
E Rationale
F Bibliography
ZA Normative references to international publications
        with their relevant European publications

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

Committee
TC 179
DocumentType
Standard
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Superseded
SupersededBy

OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more