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Position: Chinese Standard in English/GB/T 16886.11-2011
GB/T 16886.11-2011   Biological evaluation of medical devices—Part 11:Tests for systemic toxicity (English Version)
Standard No.: GB/T 16886.11-2011 Status:superseded remind me the status change

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Language:English File Format:PDF
Word Count: 9000 words Price(USD):170.0 remind me the price change

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Implemented on:2012-5-1 Delivery: via email in 1 business day
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Standard No.: GB/T 16886.11-2011
English Name: Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Chinese Name: 医疗器械生物学评价 第11部分:全身毒性试验
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: GB    National Standard
ICS Classification: 11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by: AQSIQ;SAC
Issued on: 2011-12-30
Implemented on: 2012-5-1
Status: superseded
Superseded by:GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Superseded on:2022-12-1
Superseding:GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
Language: English
File Format: PDF
Word Count: 9000 words
Price(USD): 170.0
Delivery: via email in 1 business day
1 Scope This part of GB/T 16886 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials 3 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply. 3.1 dose/dosage amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area 3.2 dose-effect relationship between the dosage and the magnitude of a defined biological effect either in an individual or in a population sample 3.3 dose-response relationship of dosage to the spectrum of effects related to the exposure Note: there are two types of dose-response relationships. The first type is the response of an individual to a range of doses. The second type is the distribution of responses of a population of individuals to a range of doses. 3.4 leachable substance chemical removed from a device or material by the action of water or other liquids related to the use of the device Note: examples of leachable substances are additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers, anti-oxidants, colouring agents, fillers and monomers. 3.5 limit test use of a single group treated at a suitable dosage of test sample in order to delineate the presence or absence of a toxic hazard 3.6 systemic toxicity toxicity that is not limited to adverse effects at the site of contact between the body and the device Note: systemic toxicity requires absorption and distribution of a toxicant from its entry point to a distant site at which deleterious effects are produced.
Foreword i Introduction iv 1 Scope 2 Normative References 3 Terms and Definitions 4 General Considerations 5 Acute Systemic Toxicity 6 Repeated Exposure Systemic Toxicity (Subacute, Subchronic and Chronic Systemic Toxicity) Annex A (Informative) Routes of Administration Annex B (Informative) Dosage Volumes Annex C (Informative) Common Clinical Signs and Observations Annex D (Informative) Suggested Haematology, Clinical Chemistry and Urinalysis Measurements Annex E (Informative) Suggested Organ List for Histopathological Evaluation Annex F (Informative) Information on Material-mediated Pyrogens Bibliography
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Code of China
Standard
GB/T 16886.11-2011  Biological evaluation of medical devices—Part 11:Tests for systemic toxicity (English Version)
Standard No.GB/T 16886.11-2011
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count9000 words
Price(USD)170.0
Implemented on2012-5-1
Deliveryvia email in 1 business day
Detail of GB/T 16886.11-2011
Standard No.
GB/T 16886.11-2011
English Name
Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Chinese Name
医疗器械生物学评价 第11部分:全身毒性试验
Chinese Classification
C30
Professional Classification
GB
ICS Classification
Issued by
AQSIQ;SAC
Issued on
2011-12-30
Implemented on
2012-5-1
Status
superseded
Superseded by
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Superseded on
2022-12-1
Abolished on
Superseding
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
Language
English
File Format
PDF
Word Count
9000 words
Price(USD)
170.0
Keywords
GB/T 16886.11-2011, GB 16886.11-2011, GBT 16886.11-2011, GB/T16886.11-2011, GB/T 16886.11, GB/T16886.11, GB16886.11-2011, GB 16886.11, GB16886.11, GBT16886.11-2011, GBT 16886.11, GBT16886.11
Introduction of GB/T 16886.11-2011
1 Scope This part of GB/T 16886 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials 3 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply. 3.1 dose/dosage amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area 3.2 dose-effect relationship between the dosage and the magnitude of a defined biological effect either in an individual or in a population sample 3.3 dose-response relationship of dosage to the spectrum of effects related to the exposure Note: there are two types of dose-response relationships. The first type is the response of an individual to a range of doses. The second type is the distribution of responses of a population of individuals to a range of doses. 3.4 leachable substance chemical removed from a device or material by the action of water or other liquids related to the use of the device Note: examples of leachable substances are additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers, anti-oxidants, colouring agents, fillers and monomers. 3.5 limit test use of a single group treated at a suitable dosage of test sample in order to delineate the presence or absence of a toxic hazard 3.6 systemic toxicity toxicity that is not limited to adverse effects at the site of contact between the body and the device Note: systemic toxicity requires absorption and distribution of a toxicant from its entry point to a distant site at which deleterious effects are produced.
Contents of GB/T 16886.11-2011
Foreword i Introduction iv 1 Scope 2 Normative References 3 Terms and Definitions 4 General Considerations 5 Acute Systemic Toxicity 6 Repeated Exposure Systemic Toxicity (Subacute, Subchronic and Chronic Systemic Toxicity) Annex A (Informative) Routes of Administration Annex B (Informative) Dosage Volumes Annex C (Informative) Common Clinical Signs and Observations Annex D (Informative) Suggested Haematology, Clinical Chemistry and Urinalysis Measurements Annex E (Informative) Suggested Organ List for Histopathological Evaluation Annex F (Informative) Information on Material-mediated Pyrogens Bibliography
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Keywords:
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