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Doplňující informace

ASTM F2042-00(2011)

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

Automaticky přeložený název:

Standardní příručka pro silikonové elastomery, gelů a pěn používaných pro lékařské účely Část II & ndash; síťování Fabrication

NORMA vydána dne 1.12.2011

Jazyk
Provedení	Online zabezpečené PDF - 1 750.90 Kč Tištěné - 1 750.90 Kč
Dostupnost	SKLADEM
Cena	1750.90 Kč bez DPH
1 750.90 Kč

Informace o normě:

Označení normy: ASTM F2042-00(2011)
Poznámka: NEPLATNÁ
Datum vydání normy: 1.12.2011
Kód zboží: NS-52561
Počet stran: 7
Přibližná hmotnost: 21 g (0.05 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ASTM F2042-00(2011) :

Keywords:

foam, gel, high consistency rubber, liquid silicone rubber, medical device material, moisture cure, peroxide cure, platinum cure, RTV, Gel foam, High-consistency rubber, Crosslinking, Liquid silicone rubber, Moisture cure, Peroxide cure, Platinum cure, Silicone surgical implant materials, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňující informace

Significance and Use

This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties.

Silicone manufacturers supplying material to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly or through the US FDA Master File program.

1. Scope

1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products.

1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical device applications.

1.3 Formulation and selection of appropriate starting materials is covered in the companion document, F2038 Part I. This monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting product is evaluated.

1.4 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use. Biocompatibility testing may be done on cured elastomers prior to final fabrication, but the most relevant data are those obtained on the finished device. Data on selected lots of material are only representative when compounding, and fabrication are performed under accepted quality systems such as ISO 9001 and current Good Manufacturing Practice Regulations. Extractables analyses may also be of interest for investigation of biocompatibility, and the procedures for obtaining such data depend on the goal of the study (see F619, the HIMA Memorandum 7/14/93, and USP 23, for examples of extraction methods).

2. Referenced Documents

F1906-98	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
D624-00(2020)	Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D430-06(2018)	Standard Test Methods for Rubber Deterioration´Dynamic Fatigue
D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D395-18	Standard Test Methods for Rubber Property´Compression Set
F1905-98	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
AAMI TIR8–251	Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
HIMA Memorandum	Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials, 7/14/93 Available from Advanced Medical Technology Association, 1200 G St. N.W. Suite 400 Washington, D.C. 20005-3814, http://www.advamed.org.
Biological Performance of Materials:	J. Black, Marcel Dekker, NY 1992
21 CFR 211	Current Good Manufacturing Practice for Finished Pharmaceuticals (current revision)
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F719-20e1	Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation (Includes all amendments and changes 11/2/2020).
F1984-99(2018)	Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F2038-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I´Formulations and Uncured Materials
D792-20	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D813-07(2019)	Standard Test Method for Rubber Deterioration´Crack Growth
D814-95(2020)	Standard Test Method for Rubber Property´Vapor Transmission of Volatile Liquids
D926-17(2022)	Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)
D955-21	Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D1349-14(2019)	Standard Practice for Rubber´Standard Conditions for Testing
D1566-21a	Standard Terminology Relating to Rubber (Includes all amendments and changes 11/10/2021).
D2240-15(2021)	Standard Test Method for Rubber Property—Durometer Hardness
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices

Podobné normy:

ASTM F2146-13

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ASTM F2183-02(2008)..

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ASTM F2193-02(2007)..

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