SFS-EN ISO 11137-2:en

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ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms

3.1 Terms and definitions
3.2 Abbreviated terms

4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing

4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.4 Maintaining product families
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family

5 Selection and testing of product for establishing the sterilization dose

5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation

6 Methods of dose establishment
7 Method 1: dose setting using bioburden information

7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches

8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor

8.1 Rationale
8.2 Procedure for Method 2A
8.3 Procedure for Method 2B

9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose

9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.3 Procedure for Method VDmax25 for a single production batch
9.4 Procedure for Method VDmax15 for multiple production batches
9.5 Procedure for Method VDmax15 for a single production batch

10 Sterilization dose audit

10.1 Purpose and frequency
10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or Method 2B
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.4 Failure of a sterilization dose audit

11 Worked examples

11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms

3.1 Terms and definitions
3.2 Abbreviated terms

4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing

4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.4 Maintaining product families
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family

5 Selection and testing of product for establishing the sterilization dose

5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation

6 Methods of dose establishment
7 Method 1: dose setting using bioburden information

7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches

8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor

8.1 Rationale
8.2 Procedure for Method 2A
8.3 Procedure for Method 2B

9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose

9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.3 Procedure for Method VDmax25 for a single production batch
9.4 Procedure for Method VDmax15 for multiple production batches
9.5 Procedure for Method VDmax15 for a single production batch

10 Sterilization dose audit

10.1 Purpose and frequency
10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or Method 2B
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.4 Failure of a sterilization dose audit

11 Worked examples

11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

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 11137-1:2006/Amd 1:2013 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
ISO 11137-1:2006/Amd 2:2018 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

Direktiivi

90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
2017/745
2017/746

http://ec.europa.eu »

Vahvistuspäivä

10.08.2015

Julkaisupäivä

28.08.2015

Painos

5

Sivumäärä

76

Julkaisun kieli

englanti