- Standard Category System

Standard Number :

SFDA.MD/IEC 62366-1:2015/AMD 1:2023

Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

Arabic Dcoument Price:

English Document Price:

657.15SR 155.00€

Issue Date:

2023

Scope:

Amendment

Decument Type :

Standard

ICS :

11.040.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 9713:2023

Neurosurgical implants — Self-closing intracranial aneurysm clips

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English Document Price:

241.20SR 57.00€

Issue Date:

2023

Scope:

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force. This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips). NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

Decument Type :

Standard

ICS :

11.040.40

Sector :

Medical Devices

Standard Number :

SFDA.DR/GSO 2646:2021

Cosmetics - Identification and determination of hexachlorophene

Arabic Dcoument Price:

English Document Price:

90.00SR 24.00$

Issue Date:

2023

Scope:

This method is suitable for all cosmetic products.

Decument Type :

Standard

ICS :

71.100.70

Sector :

Drug

Standard Number :

SFDA.DR/GSO 2632:2021

Cosmetics - Determination of zinc

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English Document Price:

75.00SR 20.00$

Issue Date:

2023

Scope:

This method is suitable for the determination of zinc present as chloride, sulphate or 4 hydroxybenzenesulphonate, or as an association of several of these zinc salts, in cosmetics.

Decument Type :

Standard

ICS :

71.100.70

Sector :

Drug

Standard Number :

GSO.DR/GSO 2633:2021

Cosmetics - Identification and determination of nitromethane

Arabic Dcoument Price:

English Document Price:

75.00SR 20.00$

Issue Date:

2023

Scope:

This method is suitable for the identification and determination of nitromethane at up to about 0,3 % in cosmetic products packed in aerosol dispensers.

Decument Type :

Standard

ICS :

71.100.70

Sector :

Drug

Standard Number :

SFDA.DR/GSO 2639:2021

Cosmetics - Determination and identification of oxalic acid and its alkaline salts in hair-care products

Arabic Dcoument Price:

English Document Price:

75.00SR 20.00$

Issue Date:

2023

Scope:

The method described below is suitable for the determination and identification of oxalic acid and its alkaline salts in hair-care products. It can be used for colourless aqueous/alcoholic solutions and lotions which contain about 5 % of oxalic acid or an equivalent quantity of alkaline oxalate.

Decument Type :

Standard

ICS :

71.100.70

Sector :

Drug

Standard Number :

SFDA.MD/ ISO 11073-10425: 2023

Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)

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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:

2023

Scope:

This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

Decument Type :

Standard

ICS :

35.240.80

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 12052: 2023

Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management

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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:

2023

Scope:

This document, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information. ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying: - for network communications, a set of protocols to be followed by devices claiming conformance to this document; - the syntax and semantics of Commands and associated information which can be exchanged using these protocols; - for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media; - information that is to be supplied with an implementation for which conformance to this document is claimed. ISO 12052:2017 does not specify: - the implementation details of any features of the DICOM standard on a device claiming conformance; - the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document; - a testing/validation procedure to assess an implementation's conformance to this document. ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field. ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments. ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

Decument Type :

Standard

ICS :

35.240.80

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 21547: 2023

Health informatics – Security requirements for archiving of electronic health records - principles

Arabic Dcoument Price:

English Document Price:

400.00SR 94.00€

Issue Date:

2023

Scope:

The purpose of this document is to define the basic principles needed to securely preserve health records in any format for the long term. It concentrates on previously documented healthcare specific archiving problems. It also gives a brief introduction to the general archiving principles. Unlike the traditional approach to standardization work, where the perspective is that of modelling, code sets and messages, this Technical Specification looks at archiving from the angle of document management and related privacy protection. In ISO/TS 21547:2010 archiving is understood to be a wider process than just the permanent preservation of selected records. ISO/TS 21547:2010 defines architecture and technology-independent security requirements for long-term preservation of EHRs having fixed content. ISO/TS 21547:2010 and a complementary Technical Report, ISO 21548, concentrate on the security requirements (integrity, confidentiality, availability and accountability) necessary for ensuring adequate protection of health information in long-term digital preservation. This Technical Specification will also address privacy protection requirements for both the EHR and eArchiving systems used in the healthcare environment. ISO/TS 21547:2010 defines functional security requirements for long term archiving of EHRs, but the practical archiving models and technology required are outside the concept of this Technical Specification.

Decument Type :

Standard

ICS :

35.240.80

Sector :

Medical Devices

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