SFS-EN ISO 11135:en

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ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope

1.1 Inclusions
1.2 Exclusions

2 Normative references
3 Terms and definitions
4 Quality management systems

4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement — Control of nonconforming product

5 Sterilizing agent characterization

5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Safety and the environment

6 Process and equipment characterization

6.1 General
6.2 Process characterization
6.3 Equipment characterization

7 Product definition

7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality
7.4 Documentation

8 Process definition
9 Validation

9.1 General
9.2 Installation qualification, IQ
9.3 Operational qualification, OQ
9.4 Performance qualification, PQ
9.5 Review and approval of validation

10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness

12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
12.5 Assessment of equivalence

Annex A Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach (normative)
Annex B Conservative determination of lethal rate of the sterilization process — Overkill approach (normative)
Annex C Temperature sensors, RH sensors and biological indicator numbers (informative)
Annex D Guidance on the application of the normative requirements (informative)
Annex E Single Lot Release (normative)

Bibliography

Näytä kaikki

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring equipment
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2006 Sterilization of health care products -- Biological indicators -- Part 1: General requirements

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

Direktiivi

90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
2017/745
2017/746

http://ec.europa.eu »

Vahvistuspäivä

01.09.2014

Julkaisupäivä

19.09.2014

Painos

1

Sivumäärä

84

Julkaisun kieli

englanti