- Standard Category System

Standard Number :

10993-18:2008

Biological evaluation of medical devices — Part 18: Chemical characterization of materials

Arabic Dcoument Price:

English Document Price:

490.75SR 119.00€

Issue Date:

2020

Scope:

This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:  As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).  Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17).  Judging equivalence of a proposed material to a clinically established material.  Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former.  Screening of potential new materials for suitability in a medical device for a proposed clinical application. This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Decument Type :

Standard

ICS :

11.100.20

Sector :

Medical Devices

Standard Number :

SFDA.MD/ IEC 80601-2-30:2020

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

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English Document Price:

707.05SR 171.00€

Issue Date:

2020

Scope:

This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION. This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2]. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.

Decument Type :

Standard

ICS :

11.040.10

Sector :

Medical Devices

Standard Number :

SFDA.CO 6000:2020

Cosmetic products – Product Information File (PIF)

Arabic Dcoument Price:

English Document Price:

100.00SR 24.00€

Issue Date:

2020

Scope:

Cosmetic products

Decument Type :

Standard

ICS :

ICS:71.100.70

Sector :

Drug

Standard Number :

SFDA.FD 58:2019

Processed Cheese and Spreadable Processed Cheese and Processed Cheese Imitation and Spreadable Processed Cheese Imitation

Arabic Dcoument Price:

80.00SR 19.00€

English Document Price:

Issue Date:

2020

Scope:

Decument Type :

Technical Regulation

ICS :

67.040.00

Sector :

Food

Standard Number :

SFDA.MD/ISO 8669-2:2019

Urine collection bags — Part 2: Requirements and test methods

Arabic Dcoument Price:

English Document Price:

366.00SR 88.00€

Issue Date:

2020

Scope:

This part of ISO 8669 specifies performance requirements and test methods for open-ended and closed-ended urine collection bags of the following types: a) urine collection bags intended to be worn on the body (body-worn bags); b) urine collection bags intended to be used with a hanger or a floor stand (non-body-worn bags). It does not apply to urostomy bags, urimeters and urine bags intended specifically for paediatric use.

Decument Type :

Standard

ICS :

11.180.20

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 7405:2020

Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

Arabic Dcoument Price:

English Document Price:

657.15SR 159.00€

Issue Date:

2020

Scope:

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body

Decument Type :

Standard

ICS :

11.060.1

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 9173-1:2020

Dentistry -- Extraction forceps -- Part 1: General requirements

Arabic Dcoument Price:

English Document Price:

158.05SR 38.00€

Issue Date:

2020

Scope:

This part of ISO 9173 specifies the general performance requirements for extraction forceps used in dentistry.

Decument Type :

Standard

ICS :

11.060.20

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 15841:2020

Dentistry -- Wires for use in orthodontics

Arabic Dcoument Price:

English Document Price:

241.20SR 58.00€

Issue Date:

2020

Scope:

This International Standard specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. This International Standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labelling information.

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

Standard Number :

SFDA.MD ISO 16506:2020

Dentistry -- Polymer-based luting materials containing adhesive components

Arabic Dcoument Price:

English Document Price:

657.15SR 159.00€

Issue Date:

2020

Scope:

This document specifies test methods and information of bond strength to dentine and physical and chemical performances of dental polymer-based luting materials containing adhesive components. The materials are supplied in a form suitable for mechanical mixing or hand-mixing, including using auto-mixing tips, for self-curing and/or external energy activation, or non-mixing for external energy activation. The polymer-based luting materials covered by this document are intended to be used for the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, posts, crowns and bridges. This document does not cover the following polymer-based luting materials: a) those which do not have an adhesive component within the structure of the material (see ISO 4049); b) those intended for veneering sub-frames (see ISO 10477).

Decument Type :

Standard

ICS :

11.060.10

Sector :

Medical Devices

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