SFS-EN ISO 11140-1:en

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ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

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Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization

4.1 General
4.2 Type 1: process indicators
4.3 Type 2: indicators for use in specific tests
4.4 Type 3: single critical process variable indicators
4.5 Type 4: multicritical process variable indicators
4.6 Type 5: integrating indicators
4.7 Type 6: emulating indicators

5 General requirements
6 Performance requirements

6.1 General
6.2 Type 1 indicators
6.3 Type 2 indicators
6.4 Types 3, 4, 5 and 6 indicators

7 Test methods

7.1 General
7.2 Off-set (transference)
7.3 Procedure — Steam indicators
7.4 Procedure — Dry heat indicators
7.5 Procedure — EO indicators
7.6 Procedure — Low temperature steam and formaldehyde indicators
7.7 Procedure — Vaporized hydrogen peroxide indicators

8 Additional requirements for process (Type 1) indicators

8.1 Process indicators printed or applied on to packaging material
8.2 Process indicators for steam sterilization processes
8.3 Process indicators for dry heat sterilization processes
8.4 Process indicators for ethylene oxide sterilization processes
8.5 Process indicators for radiation sterilization processes
8.6 Process indicators for low temperature steam and formaldehyde sterilization processes
8.7 Process indicators for vaporized hydrogen peroxide sterilization processes

9 Additional requirements for single critical process variable (Type 3) indicators
10 Additional requirements for multicritical process variable (Type 4) indicators
11 Additional requirements for steam integrating (Type 5) indicators
12 Additional requirements for ethylene oxide integrating (Type 5) indicators
13 Additional requirements for emulating (Type 6) indicators

Annex A Method for demonstrating shelf-life of the product (normative)
Annex B Examples of testing indicators (informative)
Annex C Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138 (all parts) and microbial inactivation (informative)
Annex D Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators (informative)
Annex E Relationship of indicator and indicator system components (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization

4.1 General
4.2 Type 1: process indicators
4.3 Type 2: indicators for use in specific tests
4.4 Type 3: single critical process variable indicators
4.5 Type 4: multicritical process variable indicators
4.6 Type 5: integrating indicators
4.7 Type 6: emulating indicators

5 General requirements
6 Performance requirements

6.1 General
6.2 Type 1 indicators
6.3 Type 2 indicators
6.4 Types 3, 4, 5 and 6 indicators

7 Test methods

7.1 General
7.2 Off-set (transference)
7.3 Procedure — Steam indicators
7.4 Procedure — Dry heat indicators
7.5 Procedure — EO indicators
7.6 Procedure — Low temperature steam and formaldehyde indicators
7.7 Procedure — Vaporized hydrogen peroxide indicators

8 Additional requirements for process (Type 1) indicators

8.1 Process indicators printed or applied on to packaging material
8.2 Process indicators for steam sterilization processes
8.3 Process indicators for dry heat sterilization processes
8.4 Process indicators for ethylene oxide sterilization processes
8.5 Process indicators for radiation sterilization processes
8.6 Process indicators for low temperature steam and formaldehyde sterilization processes
8.7 Process indicators for vaporized hydrogen peroxide sterilization processes

9 Additional requirements for single critical process variable (Type 3) indicators
10 Additional requirements for multicritical process variable (Type 4) indicators
11 Additional requirements for steam integrating (Type 5) indicators
12 Additional requirements for ethylene oxide integrating (Type 5) indicators
13 Additional requirements for emulating (Type 6) indicators

Annex A Method for demonstrating shelf-life of the product (normative)
Annex B Examples of testing indicators (informative)
Annex C Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138 (all parts) and microbial inactivation (informative)
Annex D Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators (informative)
Annex E Relationship of indicator and indicator system components (informative)

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
ISO 11138-1:2006 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2006 Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4:2006 Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2006 Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11140-3:2007 Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-4:2007 Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 11140-5:2007 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment
ISO 8601:2004 Data elements and interchange formats -- Information interchange -- Representation of dates and times
ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1
ISO/TS 17665-3:2013 Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Tekninen komitea

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices »

Direktiivi

90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

15.12.2014

Julkaisupäivä

02.01.2015

Painos

3

Sivumäärä

37

Julkaisun kieli

englanti