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Standard Number :

SFDA.MD/ISO 20857:2021

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Arabic Dcoument Price:

English Document Price:

740.30SR 167.00€

Issue Date:

2021

Scope:

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 14971:2021

Medical devices — Application of risk management to medical devices

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* Files of this standard are not available in the store now You can obtain this standard from the national standardization bodies in the Member States.

Issue Date:

2021

Scope:

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: — decisions on the use of a medical device in the context of any particular clinical procedure; or — business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

Decument Type :

Standard

ICS :

11.040.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 18250-6:2021

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications

Arabic Dcoument Price:

English Document Price:

158.05SR 36.00€

Issue Date:

2021

Scope:

This document specifies the connectors recommended for the outlet ports of neural reservoirs and inlet ports of neural giving sets.

Decument Type :

Standard

ICS :

11.040.25

Sector :

Medical Devices

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

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