Clau | 2014 | Influence | 2007 |
1 Scope | Nothing significant change for the industrial | ||
1.1 Inclusion | NEW Specify requirement of EO sterilization for industrial and health care facility. | ||
1.2 Exclusion | NEW 1.2.1=2007 1, DO NOT include veral kinds of inactivation 1.2.2=2007 1, DO NOT specify requirement for designating STERILE 1.2.3=2007 1, DO NOT specify a quality management system 1.2.4=2007.1, DO NOT specify occupational safety 1.2.5=2007.1, DO NOT include injecting EO to package 1.2.6=2007.1, DO NOT cover analytical method for EO residual or reaction | ||
2 Normative Reference | ISO 10012, same ISO 10993-1 DELETE ISO 10993-7 same 善假于物ISO 11138-1:2006 same ISO 11138-2:2009 version update ISO 11140-1 same ISO 11737-1 same ISO 11737-2 same ISO 13485:2003/Cor 1:2009, change ISO 14161 DELETE ISO 14937:2000 DELETE | ||
3 Term and Definition | Dew Point: NEW Health care facility: NEW Overkill approach: only term change Process challenge device: internal PCD/external PCD RLC电路Processing category: NEW Produce family: NEW Reusable medical device: NEW Single u medical device: NEW SLR: new method to calculate Sterile barrier system: NEW Sterilization specialist: NEW Test for sterility: NEW Virgin material: NEW | ||
4 Quality management system | 家国情怀的诗 | ||
4.1 Documentation | 4.1.1=2007 4.1.1, procedure for development, validation, routine control and product relea shall be specified. 4.1.2=2007 4.1.2, reviewed and approved by designated personnel, document and record according to ISO 13485 | No effect | |
| 济南自驾游 4.2 Management responsibility | 4.2.1=2007 4.2.1, responsibility and authority shall be specified according to ISO 13485 4.2.2=2007 4.2.2, organization with parate quality management system Add HCF’s responsibility | No effect | |
4.3 Production realization | 4.3.1=2007 4.3.1, purchasing procedure 4.3.2=2007 4.3.2, procedure for identification and traceability 4.3.3=2007 4.3.3, quality management system for calibration | No effect | |
4.4 Measurement, analysis and improvement | =2007 4.4, procedure for nonconforming product and for correction, corrective action and preventive action. | No effect | |
5 Sterilizing agent characterization | |||
5.1 General | NEW Purpo | ||
5.2 Sterilizing agent | =2007 5.1, composition, storage | Description change while the content keep the same | |
5.3 Microbicidal effectiveness | =2007 5.2, recognized range of EO and diluents, otherwi microbicidal effectiveness shall be developed. | ||
5.4 Material effects | =2007 5.3, EO’s effect on materials ud to Medical Device. DELETE the description of recording | ||
5.5 Safety and environment | 5.5.1, NEW, MSDS of EO and diluents needed, health and safety of personnel 5.5.2=2007 5.4.1, environment protect 5.5.3=2007 5.4.2, ur of EO | ||
6 Process and equipment characterization | 青豆虾仁 | kuli | |
6.1 General | 6.1.1, NEW, purpo 6.1.2, NEW, if a sterilization process existing, then ignore this | ||
6.2 Process characterization | 6.2.1, NEW, Process characterization shall include a), identifying the pha for EO cycle b), identifying the variables for each pha c) document the variables 6.2.2=2007 6.1.2, pha of sterilization a), preconditioning b), sterilization cycle c), aeration 6.2.3, NEW, variables for preconditioning a), time b), temp c), humidity d), transfer time 6.2.4,NEW, variable for sterilization cycle a), exposure time b), temp c), humidity d), EO concentration e), pressure 6.2.5, NEW, variable for aeration, note for aeration variable a), time b), temp DELETE 2007 6.1.1 DELETE 2007 6.1.3 the characterization of sterilization cycle一年级的小豌豆 DELETE 2007 6.1.4 the controlled treatment condition DELETE 2007 6.1.5 tolerance DELETE 2007 6.1.6 means of monitoring and controlling | ●Range of variable and equipment shall be documented | |
6.3 Equipment characterization | 6.3.1=2007 6.2.1, specification of equipment shall include a), the preconditioning area b), the sterilizer c), the aeration area 6.3.2=2007 6.2.2, specification shall include a)=2007 a), description of equipment, ancillary items, material of construction b)<2007 b), description of means of delivering sterilizing agent to chamber c)=2007 c), description of means of delivering other gas or steam to chamber d)=2007 e), description of instrumentation for monitoring, controlling and recording e)=2007 f), fault recognition f)=2007 g), safety feature g)=2007 h), installation requirement 6.3.3=2007 6.2.3, software shall be prepared and validated to meet its specification 6.3.4=2007 6.2.4, means to ensure failure in control function does not lead to failure in recording which lead to a fake positive | ||
7 Product definition | |||
7.1 General | 7.1.1, NEW, purpo: define the product to be sterilized prior to the sterilization, including the microbiological quality and package 7.1.2=2007 7.1.1+7.1.2 7.1.3<2007 7.1.3, product shall be designed to allow the removal of air and EO, etc, DELETE the most difficult-to-sterilized location for product 7.1.4=2007 7.1.4, package shall be designed to allow the removal of air and EO, etc 7.1.5, NEW, load configuration shall be designed to allow the removal of air and EO, etc 7.1.6>2007 7.1.5, It can be achieved by 3 ways to demonstrate the specified sterilization process is effective in sterilizing the most difficult-to-sterilize location within the product instead of may be. | ||
7.2 Product safety, quality and performance | 7.2.1=2007 7.2.1, the most challenging process parameter of product and package. 7.2.2<2007 7.2.2, evaluate multiple cycle’s effect on product, DELETE ISO 17664 7.2.3=2007 7.2.3, establish the biological safety of product endured the cycle 7.2.4=2007 7.2.4, reduce the EO residual | ||
7.3 Microbiological quality | 7.3.1=2007 7.3.1, system to control microbiological quality and cleanliness. Add quotation of bacterial endotoxins related standard and literature. 7.3.2=2007 7.3.2, system’s effectiveness for single and reusable medical device shall be demonstrated. | ||
7.4 Documentation | >2007 7.4, documentation shall be done by manufacturer of the device | ||
8 Process definition | |||
8.1 | NEW, purpo, obtain a process specification for the sterilization of product during the validation studies. | ||
8.2 | =2007 8.1+8.3, sterilization shall be established for new or modified product, packaging or loading configuration. | ||
8.3 | =2007 8.2, sterilization chamber shall be IQed and OQed. | ||
8.4 | =2007 8.4, documentation and records | ||
8.5 | =2007 8.5, rate of microbiological inactivation shall be determined by the method provided in annexes or alternative method achieving the same SAL | ||
8.6 | =2007 8.6, BI and PCD requirement | ||
8.7 | =2007 8.7, commercially supplied BI requirement shall comply with 8.6 and ISO 11138-1 | ||
8.8 | =2007 8.8, chemical indicators shall comply with ISO 11140-1 | ||
8.9 | =2007 8.9, test of sterility shall comply with ISO 11737-2 | ||
9 Validation | |||
9.1 General | New 9.1.1, Purpo, validation consists of 3 stages: IQ, OQ, PQ. 9.1.2 ,Purpo of IQ 9.1.3, Purpo of OQ 9.1.4, Purpo of PQ, difference of IOQ and PQ | ||
9.2 IQ | =2007 9.1 | ||
9.2.1 Equipment | New 9.2.1.1 =2007 9.1.1 and 9.1.2 9.2.1.2, New safety standard 9.2.1.3=2007 9.1.3 | ||
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