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YY/T 1464-2022: (Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes)
Status: Valid YY/T 1464: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1464-2022 | English | 859 |
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(Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes)
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YY/T 1464-2022
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| YY/T 1464-2016 | English | 1319 |
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Sterilization of medical devices. Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
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YY/T 1464-2016
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PDF similar to YY/T 1464-2022
Basic data | Standard ID | YY/T 1464-2022 (YY/T1464-2022) | | Description (Translated English) | (Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Word Count Estimation | 39,382 | | Date of Issue | 2022-10-17 | | Date of Implementation | 2023-10-01 | | Older Standard (superseded by this standard) | YY/T 1464-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for the development, validation and routine control of the low temperature steam formaldehyde sterilization process for medical devices. This standard applies to the sterilization process using mixed low-temperature steam formaldehyde as a sterilization factor under negative pressure conditions. This standard does not apply to the requirements for the development, validation and routine control of spongiform encephalopathy (such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease) pathogen inactivation process. | YY/T 1464-2016: Sterilization of medical devices. Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
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Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
ICS 11.080.01
C47
People's Republic of China Pharmaceutical Industry Standard
Sterilization of medical equipment - Low temperature steam formaldehyde sterilization
Process development, validation and routine control requirements
Sterilization ofmedicaldevices-Requirementsforthedvelopment,
(ISO 25424..2009, Sterilization ofmedicaldevices-
formedicaldevices, IDT)
2016-01-26 Release.2017-01-01 Implementation
State Food and Drug Administration issued
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 25424..2009 "Sterilization of Medical Devices Sterilization Low Temperature Steam Formaldehyde Medical Devices Sterilization Process
Development, validation and routine control requirements ".
This standard has made the following editorial changes.
--- As the standard name of the first paragraph of "medical device sterilization" has been limited to the scope of application of the standard medical device for sterilization, the standard
Quasi-name changed to "medical device sterilization low temperature steam formaldehyde sterilization process development, confirmation and conventional control requirements."
And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.
YY 0679-2008 Medical low temperature steam formaldehyde sterilizers (EN14180..2003, NEQ);
GB 18281.1-2015 Sterilization products for health care products - Part 1. General principles (ISO 11138-1..2006,
IDT);
GB 18282.1-2015 Sterilization products for health care products - Part 1. General principles (ISO 11140-1..2005,
IDT);
GB/T.19973.1-2015 Sterilization methods for medical devices - Part 1. Determination of the total number of microorganisms on a product
(ISO 11737-1..2006, IDT);
GB/T.19973.2-2005 Sterilization methods for medical devices - Part 2. Sterilization test for sterilization procedures
(ISO 11737-2..1998, IDT);
Medical Device Quality Management System for Regulatory Requirements (ISO 13485..2003, IDT) - YY/T 0287-2003.
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 inspection
Heart, Guangdong Province Food and Drug Administration review and certification center.
The main drafters of this standard. Qiuwei Yu, Wang Hongmin, Sun Zhigang, Zhang Haijun.
Introduction
Sterile medical devices are products that have no surviving 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 if the medical device production
The products are produced under standard manufacturing conditions that meet the requirements of the quality management system (eg ISO 13485) and will still be shipped with a small amount
Of the micro-organisms, such products are non-sterile products. The purpose of sterilization is to inactivate microorganisms and convert 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. Therefore, any one of the sterilized processed batch products can not be guaranteed to be sterile, and the batch
The sterility of the product is defined as the probability of the presence of living microorganisms in the medical device.
Meet the requirements of this standard can provide a suitable for medical devices with appropriate microbial activity to kill low-temperature steam formaldehyde sterilization
process. In addition, sterilization according to this standard ensures its reliability and reproducibility, and it can be considered that the probability of microbial survival after sterilization is
low. The probability of virological viability required to meet sterility is regulated by regulatory authorities and may vary from country to country (eg YY/T 0615.1).
Design and development, production, installation and service of the general requirements of quality management system see GB/T 19001, the quality of medical equipment production
See ISO 13485 for the special requirements of the management system. These quality management system standards that the process of manufacturing some of the effectiveness of the law can not be complete
Through the subsequent product testing and testing to verify that sterilization belongs to this process. Therefore, the sterilization process should be confirmed before the implementation of the sterilization
The effectiveness of the program should be routine monitoring and maintenance of the equipment.
Exposure to approved and accurately controlled sterilization processes is not the only factor that ensures that the product is sterile and suitable for the intended use. therefore
Also note the following.
a) the microbial status of the raw materials and/or components used;
b) any conventional control and confirmation of the cleaning and disinfection procedures used 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) the transport and storage conditions of the product.
The type of contamination of the sterilized product affects the effectiveness of the sterilization process. It is best to use the medical institution and follow the manufacturer's instructions
Each of the products required for re-sterilization (see ISO 17664) is considered a special case. Despite the clean, these products may still be extensive
Microbiological contamination, and residual organic and/or inorganic contamination. Therefore, special attention should be paid to the process of cleaning and disinfecting the equipment during repeated treatment
Confirmation and control.
The guidance in the informative appendix is not a normative requirement and is not provided as an assessor of the assessor. The explanation given in the guide
Justice and methods should be considered appropriate means to meet the requirements of the standard. If you can also meet the requirements of this standard, the guidelines do not give the method also
Can 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. Although the activities specified in this standard are grouped and arranged in a specific order, this does not
Requiring that these activities be carried out in the order of the standard. The required behavior is not necessarily the second time, because the process of development and confirmation
May need to be implemented repeatedly. The implementation of different acts may involve several independent individuals and/or organizations, each of which may
The implementation of one or more acts. This standard does not require a particular individual or organization to perform an action.
The activities required by this standard may also have an impact on the environment, which should be considered and minimized. Environmental requirements are attached
Record D.
Sterilization of medical equipment - Low temperature steam formaldehyde sterilization
Process development, validation and routine control requirements
1 Scope
1.1 Applicable
1.1.1 This standard specifies the requirements for the development, validation and routine control of the low temperature steam formaldehyde sterilization process in medical devices.
Note. Although the scope of this standard is limited to medical devices, the requirements and guidelines provided by it are applicable to other products and equipment.
1.1.2 This standard applies to process developers, manufacturers of sterilization equipment, manufacturers of sterilized medical devices, and sterilized medical devices
Units for sterilization of medical devices (see Table E.1 in GB/T.19974-2005).
1.1.3 This standard covers the use of mixed low temperature steam formaldehyde as a sterilizer, only below the environmental pressure of the sterilization process.
1.2 Not applicable
1.2.1 This standard does not provide for the development of corneal inactivation processes for spongiform encephalopathy (eg, itching, bovine spongiform encephalopathy and CJ)
And conventional control requirements. Some countries have developed specific specifications for the treatment of materials that are potentially contaminated by these pathogens.
1.2.2 This standard does not specify the specific requirements for "sterile" medical devices.
1.2.3 This standard does not provide for the quality management system at all stages of the control of medical device production.
Note. This standard is not required to produce a complete quality management system, it is only necessary for the control of the sterilization process required for the minimum quality management
The essential elements of the system, which are normative in the appropriate place in the text (see, for example, Chapter 4). Should be concerned about the control of medical equipment production
The quality management system at all stages (including the sterilization process) (see ISO 13485). Some countries and regions may require the provision of medical devices
Implement a complete quality management system and be evaluated by a third party. For more guidance see E.2 of GB/T.19974-2005.
1.2.4 This standard does not specify occupational safety requirements related to the design and operation of low temperature steam formaldehyde sterilization facilities.
Note 1. Operational safety requirements are specified by IEC 61010-2-040.
Note 2. Pay attention to national safety regulations.
1.2.5 This standard does not include the analytical method for determining the level or residual formaldehyde and/or its reaction product.
Note 1. Concerned about the requirements in EN14180.
Note 2. Note that there may be some restrictions on formaldehyde residues in medical device products prescribed by national regulatory regulations.
1.2.6 This standard does not include pre-sterilization prior to pretreatment, such as cleaning, disinfection and packaging.
Note. For reproducible medical devices, the manufacturer should provide pre-processed information (see ISO 17664).
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.
GB 18281.5-2015 Sterilization of biological products for health care products - Part 5. Biological instructions for low temperature steam formaldehyde sterilization
(ISO 11138-5..2006, IDT)
ISO 11138-1 Sterilization products for health care products - Part 1. General principles (Sterilization ofhealthcare
products-Biologicalindirectors-Part 1. Generalrequirements (ISO 11138-1..2006)
ISO 11140 Healthcare products Sterilization ofhealthcare products -
dicators
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