ДСТУ EN ISO 11137-2:2018 Стерилізація виробів медичної призначеності. Радіаційна стерилізація. Частина 2. Установлення стерилізувальної дози (EN ISO 11137-2:2015, IDT; ISO 11137-2:2013, IDT)

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Наказ від 14.12.2018 № 488

EN ISO 11137-2:2015

Sterilization of health care products — Radiation —
 Part 2: Establishing the sterilization dose
(ISO 11137-2:2013)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 11137-2:2018
(EN ISO 11137-2:2015, IDT; ISO 11137-2:2013, IDT)

Стерилізація виробів медичної призначеності.
 Радіаційна стерилізація.
Частина 2. Установлення стерилізувальної дози

З наданням чинності від 2019–01–01

Contents

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 VD_max — Substantiation of 25 kGy or 15 kGy as the sterilization dose

9.1 Rationale

9.2 Procedure for Method VD_max²⁵ for multiple production batches

9.3 Procedure for Method VD_max²⁵ for a single production batch

9.4 Procedure for Method VD_max¹⁵ for multiple production batches

9.5 Procedure for Method VD_max¹⁵ 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 VD_max²⁵ or Method VD_max¹⁵

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 VD_max

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 VD_max²⁵

Bibliography