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YY 1276-2016 English PDF

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YY 1276-2016: (Development, validation and routine control requirements for dry heat sterilization of medical devices)
Status: Valid

YY 1276: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 1276-2016	English	979	Add to Cart	6 days [Need to translate]	(Development, validation and routine control requirements for dry heat sterilization of medical devices)	Valid	YY 1276-2016
YY/T 1276-2016	English	979	Add to Cart	7 days [Need to translate]	Requirements for the development, validation and routine control of dry heat sterilization process for medical devices	Valid	YY/T 1276-2016

PDF similar to YY 1276-2016

Standard similar to YY 1276-2016

YY/T 1268 YY 1277 YY/T 1302.2

Basic data

Standard ID	YY 1276-2016 (YY1276-2016)
Description (Translated English)	(Development, validation and routine control requirements for dry heat sterilization of medical devices)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C47
Word Count Estimation	49,478
Issuing agency(ies)	State Food and Drug Administration

YY/T 1276-2016: Requirements for the development, validation and routine control of dry heat sterilization process for medical devices

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Requirements for the development, validation and routine control of dry heat sterilization process for medical devices ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Medical equipment dry heat sterilization process development, Confirmation and routine control requirements Requirementsforthedevelopment, validationandroutinecontrolof (ISO 20857..2010, Sterilization ofhealthcareproducts-Dryheat- Requirementsforthedevelopment, validationandroutinecontrolof asterilizationprocessformedicaldevices, IDT) 2016-03-23 Release.2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 2 4 quality management system elements 8 Characteristics of sterilization factors 6 Description of the process and equipment 9 7 Product definition 11 8 Process definition 11 9 Confirmation 12 Routine monitoring and control 11 sterilization/de-pyrogen product release 16 12 to maintain the effectiveness of the process 16 Appendix A (informative) Guidelines for Application of Standards 18 Appendix B (informative) Definition of processes based on inactivation of microbial populations in natural conditions (based on bioburden methods) 35 Appendix C (informative) Procedures based on reference to microbial inactivation and bioburden (bioburden/biological indicator) knowledge Definition 37 Appendix D (informative) Conventional process determination based on reference microbial inactivation (over-killing) 39 Appendix E (informative) Process development 41 Reference 43

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the translation method equivalent to ISO 20857..2010 "health care products sterilization dry heat medical device sterilization process Issued, confirmed and routine control requirements "(English version). And the normative reference in this standard international documents have a consistent correspondence between the Chinese documents as follows. GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (IEC 61010 - 1-2001, IDT) GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT) GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable materials (ISO 10993- 17..2002, IDT) GB 18281.1-2015 Sterilization products for health care products - Part 1. General principles (ISO 11138-1..2006, IDT) GB 18281.4-2015 Sterilization products for health care products - Part 4. Biological indicators for dry heat sterilization (ISO 11138-4..2006, IDT) GB 18282.1-2015 Sterilization products for sterilization products for health care products - Part 1. General principles (ISO 11140-1..2005, IDT) GB/T 19022-2003 Measurement management systems Requirements for measuring and measuring equipment (ISO 10012..2003, IDT) GB/T 19633.1-2015 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging systems Requirements (ISO 11607-1..2006, IDT) GB/T 19633.2-2015 Packaging of final sterilized medical devices - Part 2. Requirements for confirmation of forming, sealing and assembly processes (ISO 11607-2..2006, IDT) GB/T.19973.1-2015 Sterilization methods for medical devices - Part 1. Estimates of total microbes on products (ISO 11737-1..2006, IDT) YY/T 0287-2003 Medical device quality management system for regulatory requirements (ISO 13485..2003, IDT) Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized. The drafting of this standard. Shandong Xinhua Medical Devices Co., Ltd., the State Food and Drug Administration Guangzhou Medical Equipment Quality Supervision Supervisory center. The main drafters of this standard. Liu Yongbao, Qiuwei Yu, Wang Hongmin, Hu Changming, Zhu Xiaoming.

Introduction

Sterile medical equipment is a product without live microbes. This standard specifies the validation of the sterilization process and the routine control requirements when the medical treatment When the device must be supplied in a sterile form, a variety of unintended microbial contamination should be minimized before sterilization. Even medical device products Is produced under standard manufacturing conditions required to meet the requirements of the quality management system (eg YY/T 0287-2003), and will be accompanied by less The amount of microorganisms, such products are non-sterile products. The purpose of sterilization is to inactivate microorganisms, thereby converting non-sterile products into sterile products. The kinetics of inactivation of microbial inactivation by the physical and/or chemical factors of sterilization of medical devices can generally be used for residual microbes The exponential relationship between the number of substances and the degree of sterilization is well described. This means that regardless of the degree of sterilization, there must be microbial survival Live probability. For the treated method, the survival probability of the residual microorganism depends on the number of microorganisms, the resistance and the microbes in the process The existence of the environment. As a result, any product of sterilized processed batch products can not be guaranteed to be absolutely sterile and sterilized Of the sterility of the batch product is defined as the probability of the presence of living microorganisms in the medical device. This standard describes the requirements for dry heat sterilization of medical devices; satisfying these requirements can be achieved by appropriate microbial sterilization Sterilized medical devices provide dry heat sterilization process; in addition, can also ensure that the sterilization is reliable and repeatable, the results can be sterilized So that the probability of living microorganisms present on the product after sterilization is low. The sterility assurance level (SAL) is governed by regulations Sector identification, varies by country (eg EN556-1). Design and development, production, installation and service quality management system, see the general requirements see GB/T 19001-2008, special requirements see YY/T 0287-2003. These quality management system standards that some of the process of manufacturing efficiency can not be completely through the follow-up products Inspection and testing to confirm that sterilization is such a special process. Therefore, sterilization should be carried out before sterilization to perform routine monitoring and equipment maintain. Appropriate sterilization is carried out to precisely control the sterilization process, not the only reliable guarantee that the product is sterile and intended for use. Should also be Consider the following. a) the microbial status of the raw materials and/or components used; b) regular control and validation of the cleaning and disinfection procedures for the product; c) control of product manufacturing, assembly and packaging environments; d) control of equipment and processes; e) control of personnel and their health; f) the packaging and packaging materials of the product; g) Storage conditions of the product. The above also is used to ensure that the pyrogen is used. The type of contamination of the sterilized product affects the effectiveness of the sterilization process. Has been used in the health care environment and can be said according to the manufacturer (See YY/T 0802) for re-sterilization of the product can be used as a special case. These products despite the cleaning, but there will be potential A large number of polluting microorganisms and organic or inorganic pollution. Therefore, the confirmation and control of the cleaning and disinfection process during reprocessing is to be given in particular To be concerned. This standard is a normative requirement and must be implemented. The guidelines given in the normative appendices are not normative and can not be examined as auditors table. The guide provides an explanation and as an appropriate method to meet the requirements. Not in the guidelines within the other methods, if the requirements are positive Role can also be used. The development, validation and routine control of the sterilization process involves several incoherent but relevant activities such as calibration, maintenance, product definition, Cheng definition, installation and identification, operational identification and performance appraisal. The activities required by this standard are organized in a certain order, but do not The order in which these activities are carried out is consistent with the order in which they appear in the standard. The development and validation process may be repeated, so this is the case Some of the necessary activities are not necessarily continuous. Implementing different activities may include several individual individuals and/or organizations, each of them May bear one or more activities. This standard does not require a particular individual or organization to perform a particular activity. Medical equipment dry heat sterilization process development, Confirmation and routine control requirements

1 Scope

1.1 Applicable 1.1.1 This standard specifies the development, validation and routine control requirements of medical devices during dry heat sterilization. Note. This standard applies to medical devices, but these requirements and the guidelines provided also apply to other health care products. 1.1.2 This standard deals primarily with dry heat sterilization and also provides for the requirement of pyrogenic processes for the use of dry heat for sterilization and provides guide. Note. Dry heat is usually used for pyrolysis of equipment parts and health care products. The process parameters for sterilization and pyrogenization are time and temperature. Because to the hot conditions Usually than the sterilization required by the strict conditions, so do not need other confirmation conditions, the product to the pyrogen to confirm the process can guarantee Products are sterile. 1.2 Not applicable 1.2.1 This standard does not provide for the inactivation of such as scrapie, bovine spongiform encephalopathy, gram - ya and other spongiform encephalopathic pathogens of the sterilization process Development, confirmation, routine control requirements. Note. see YY/T 0771.1-2009, YY/T 0771.2-2009, ISO 22442-3. 1.2.2 This standard does not apply to infrared or microwave sterilization. 1.2.3 This standard does not specify the medical device identified as "sterile", see EN556-1. Note. Pay attention to the requirements of the country or place identified as "sterile" medical devices. 1.2.4 This standard does not specify the quality control system of all production stages of medical device products. Note. This standard does not need to establish a complete quality management system in the manufacturing process, but the quality management system at least to control the sterilization process with reference to the standard The applicable clause (see Chapter 4). Should take into account the quality management system standards (see YY/T 0287-2003) in the medical device including the sterilization process Production of the whole process of production. Certain regions and countries in the provisions of medical devices, requiring the implementation of a complete quality management system, and by the third party review Nuclear system. 1.2.5 This standard does not specify the occupational safety requirements associated with the design and operation of dry heat sterilization and de-thermal equipment. Note. The requirements for operational safety are specified in IEC 61010-2-040..2005.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. ISO 10012 measurement management system Measurement process and measurement equipment requirements (Measurementmanagementsystems- Requirementsformeasurementprocessesandmeasuringequipment ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (Biologicalevalua- tionofmedicaldevices-Part 1. Evaluationandtestingwithinariskmanagementprocess) ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable materials (Biological evaluationofmedicaldevices-Part 17. Establishmentofalowablelimitsforleachablesubstances ISO 11138-1..2006 Sterilization products for health care products - Part 1. General principles (Sterilization ofhealth

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