- Standard Category System

Standard Number :

SFDA.MD/ISO 7886-2:2021

Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps

Arabic Dcoument Price:

English Document Price:

366.00SR 82.00€

Issue Date:

2021

Scope:

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Decument Type :

Standard

ICS :

11.040.25

Sector :

Medical Devices

Standard Number :

SFDA.FD 2500:2021

Additives Permitted for Use in Food Stuffs

Arabic Dcoument Price:

English Document Price:

Issue Date:

2021

Scope:

Decument Type :

Technical Regulation

ICS :

67.220.20

Sector :

Food

Standard Number :

SFDA.FD147:2021

HONEY

Arabic Dcoument Price:

130.00SR 29.00€

English Document Price:

Issue Date:

2021

Scope:

Decument Type :

Technical Regulation

ICS :

67.180.10

Sector :

Food

Standard Number :

SFDA.FD 55:2021

Food Supplements

Arabic Dcoument Price:

170.00SR 38.00€

English Document Price:

Issue Date:

2021

Scope:

Decument Type :

Technical Regulation

ICS :

67.040

Sector :

Food

Standard Number :

SFDA.MD/ISO 80369-20:2021

Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods

Arabic Dcoument Price:

English Document Price:

573.95SR 129.00€

Issue Date:

2021

Scope:

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.

Decument Type :

Standard

ICS :

11.040.25

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 25424:2021

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

Arabic Dcoument Price:

English Document Price:

657.15SR 148.00€

Issue Date:

2021

Scope:

1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment. 1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1). 1.2 Exclusions 1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3. 1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1. 1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing. NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).

Decument Type :

Standard

ICS :

11.080.01

Sector :

Medical Devices

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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English Document Price:

* 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

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