- Standard Category System

Standard Number :

SFDA.MD ISO 20126:2020

Dentistry -- Manual toothbrushes -- General requirements and test methods

Arabic Dcoument Price:

English Document Price:

241.20SR 58.00€

Issue Date:

2020

Scope:

This International Standard specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This International Standard does not apply to manual interdental brushes and powered oral hygiene devices, as these instruments are covered by separate International Standards.

Decument Type :

Standard

ICS :

97.170

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 22112:2020

Dentistry -- Artificial teeth for dental prostheses

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English Document Price:

366.00SR 88.00€

Issue Date:

2020

Scope:

This document specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 22674:2020

Dentistry -- Metallic materials for fixed and removable restorations and appliances

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English Document Price:

657.15SR 159.00€

Issue Date:

2020

Scope:

This International Standard classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party. This International Standard does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 16201:2019

Technical aids for persons with disability — Environmental control systems for daily living

Arabic Dcoument Price:

English Document Price:

241.20SR 58.00€

Issue Date:

2020

Scope:

This International Standard specifies functional and technical requirements and test methods for environmental control systems intended for use to alleviate or compensate for a disability. NOTE Such systems are also known as electronic aids to daily living. The aim of this International Standard is to provide safety requirements and recommendations for manufacturers of such environmental control systems. Target devices are not covered by this International Standard. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds.

Decument Type :

Standard

ICS :

11.180.01

Sector :

Medical Devices

Standard Number :

10993-2:2008

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Arabic Dcoument Price:

English Document Price:

366.00SR 88.00€

Issue Date:

2020

Scope:

This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

Standard Number :

10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Arabic Dcoument Price:

English Document Price:

823.50SR 199.00€

Issue Date:

2020

Scope:

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

Standard Number :

10993-9:2008

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Arabic Dcoument Price:

English Document Price:

241.20SR 58.00€

Issue Date:

2020

Scope:

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

Standard Number :

10993-12:2008

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Arabic Dcoument Price:

English Document Price:

490.75SR 119.00€

Issue Date:

2020

Scope:

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: — test sample selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of, and requirements, for reference materials; — preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

Standard Number :

10993-13:2008

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Arabic Dcoument Price:

English Document Price:

366.00SR 88.00€

Issue Date:

2020

Scope:

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only non-resorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B). The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

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