- Standard Category System

Standard Number :

SFDA.MD/ISO 27020:2021

Dentistry — Brackets and tubes for use in orthodontics

Arabic Dcoument Price:

English Document Price:

241.20SR 54.00€

Issue Date:

2021

Scope:

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405

Decument Type :

Standard

ICS :

11.060.20

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 11737-1:2021

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Arabic Dcoument Price:

English Document Price:

657.15SR 148.00€

Issue Date:

2021

Scope:

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Decument Type :

Standard

ICS :

07.100.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 22254:2021

Dentistry — Manual toothbrushes — Resistance of tufted portion to deflection

Arabic Dcoument Price:

English Document Price:

241.20SR 54.00€

Issue Date:

2021

Scope:

ISO 22254:2005 specifies a test method for determining the resistance of the tufted portion of manual toothbrushes to deflection. This International Standard is applicable to toothbrushes having a conventional flat trim design and may not be applicable to toothbrushes with other designs. The results obtained with this International Standard may not correspond to consumer perceptions of the stiffness of toothbrush bristles.

Decument Type :

Standard

ICS :

97.170

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 11138-7:2021

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

Arabic Dcoument Price:

English Document Price:

740.30SR 167.00€

Issue Date:

2021

Scope:

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 9693:2021

Dentistry — Compatibility testing for metal-ceramic and ceramic-ceramic systems

Arabic Dcoument Price:

English Document Price:

241.20SR 54.00€

Issue Date:

2021

Scope:

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 11138-4:2021

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes

Arabic Dcoument Price:

English Document Price:

241.20SR 54.00€

Issue Date:

2021

Scope:

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 11138-3:2021

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes

Arabic Dcoument Price:

English Document Price:

241.20SR 54.00€

Issue Date:

2021

Scope:

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 11138-2 2021

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

Arabic Dcoument Price:

English Document Price:

158.05SR 36.00€

Issue Date:

2021

Scope:

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety.

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 4049:2021

Dentistry — Polymer-based restorative materials

Arabic Dcoument Price:

English Document Price:

573.95SR 129.00€

Issue Date:

2021

Scope:

This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting. The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506). The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

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