BS EN ISO 11135:2014+A1:2019

1.1 Inclusions

This International Standard 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.

NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.

NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.

NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.

NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-sensitive medical devices that cannot be moist heat sterilized.

NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.

1.2 Exclusions

1.2.1

This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE See ISO 22442‑1 , ISO 22442‑2 and ISO 22442‑3 .

1.2.2

This International Standard does not detail a specified requirement for designating a medical device as sterile.

NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556‑1 or ANSI/AAMI ST67.

1.2.3

This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485 ) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.

1.2.4

This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.

NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.

1.2.5

This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.

NOTE See ISO 14937 for these types of EO processes.

1.2.6

This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.

NOTE 1 For further information see ISO 10993‑7 .

NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.

PDF Catalog

PDF Pages	PDF Title
2	National foreword
4	European foreword Anchor 7 Foreword to amendment A1
6	Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices [OJ L 189] aimed to be covered
8	Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be covered
10	Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L 331] aimed to be covered
12	Annex ZD (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
15	Annex ZE (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
19	Foreword
20	Introduction
23	1 Scope 1.1 Inclusions 1.2 Exclusions
24	2 Normative references
25	3 Terms and definitions
32	4 Quality management systems 4.1 Documentation
33	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
34	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
35	6.3 Equipment characterization
36	7 Product definition 7.1 General
37	7.2 Product safety, quality and performance 7.3 Microbiological quality 7.4 Documentation 8 Process definition
38	9 Validation 9.1 General
39	9.2 Installation qualification, IQ 9.2.1 Equipment 9.2.2 Installation qualification 9.3 Operational qualification, OQ
40	9.4 Performance qualification, PQ 9.4.1 General 9.4.2 Performance qualification — Microbiological
41	9.4.3 Performance qualification — Physical
42	9.5 Review and approval of validation
44	10 Routine monitoring and control
45	11 Product release from sterilization 12 Maintaining process effectiveness 12.1 General
46	12.2 Maintenance of equipment 12.3 Requalification 12.4 Assessment of change
47	12.5 Assessment of equivalence 12.5.1 Process Equivalence 12.5.2 Product
48	Annex A (normative) Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach
49	Annex B (normative) Conservative determination of lethal rate of the sterilization process — Overkill approach
51	Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers
54	Annex D (informative) Guidance on the application of the normative requirements
96	Annex E (normative) Single batch release
99	Bibliography

Status	Under Review
Title	Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
Corrects	BS EN ISO 11135:2014+A1:2019
Replaces	BS EN ISO 11135-1:2007, DD CEN ISO/TS 11135-2:2008
Publisher	BSI
Committee	CH/198
Pages	102
Publication Date	2020-01-15
ISBN	978 0 539 12708 9
Standard Number	BS EN ISO 11135:2014+A1:2019
Identical National Standard Of	EN ISO 11135:2014/A1:2019, ISO 11135:2014/Amd.1:2018, ISO 11135:2014/Amd 1:2018
Descriptors	Verification, Medical instruments, Quality control, Microbiological analysis, Performance, Sterile equipment, Instructions for use, Sterilizers, Personnel, Sterilization (hygiene), Acceptance (approval), Hygiene, Medical equipment, Maintenance, Performance testing, Management, Ethylene oxide
ICS Codes	11.080.01 - Sterilization and disinfection in general