- Standard Category System

Standard Number :

SFDA.MD/ IEC 80001-1: 2023

Health informatics – Application of risk management for IT- networks incorporating medical devices – Part 1: Roles, responsibilities and activities

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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 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.

Decument Type :

Standard

ICS :

11.040.01

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 16054:2023

Implants for surgery — Minimum data sets for surgical implants

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English Document Price:

158.05SR 37.00€

Issue Date:

2023

Scope:

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event. This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up. It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

Decument Type :

Standard

ICS :

11.040.40

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 8827:2023

Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements

Arabic Dcoument Price:

English Document Price:

158.05SR 37.00€

Issue Date:

2023

Scope:

Specification of dimensions, tolerances, forms and designation of staples. The different forms are illustrated. The informative annex gives guidance on the selection and use of staples.

Decument Type :

Standard

ICS :

11.040.40

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 19227:2023

Implants for surgery -- Cleanliness of orthopedic implants -- General requirements

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English Document Price:

366.00SR 86.00€

Issue Date:

2023

Scope:

ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process. ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards. ISO 19227:2018 applies to in-process cleaning and final cleaning. ISO 19227:2018 does not apply to liquid or gaseous implants. ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

Decument Type :

Standard

ICS :

11.040.40

Sector :

Medical Devices

Standard Number :

SFDA.MD/ ISO 27186:2023

Active implantable medical devices -- Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

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823.50SR 194.00€

Issue Date:

2023

Scope:

This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This document does not specify all connector features. This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.

Decument Type :

Standard

ICS :

11.040.40

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 10079-4:2023

Medical suction equipment — Part 4: General requirements

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English Document Price:

573.95SR 135.00€

Issue Date:

2023

Scope:

This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; b) syringes; c) dental suction equipment; d) anaesthetic gas scavenging systems; e) laboratory suction; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) ventouse (obstetric) equipment; j) suction equipment marked for endoscopic use only; and k) plume evacuation systems.

Decument Type :

Standard

ICS :

11.040.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 21917:2023

Anaesthetic and respiratory equipment — Voice prostheses

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English Document Price:

241.20SR 57.00€

Issue Date:

2023

Scope:

This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.

Decument Type :

Standard

ICS :

11.040.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 80601-2-85:2023

Medical electrical equipment — Part 2-85: Particular requirements for basic safety and essential performance of cerebral tissue oximeter equipment

Arabic Dcoument Price:

English Document Price:

823.50SR 194.00€

Issue Date:

2023

Scope:

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use. NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.

Decument Type :

Standard

ICS :

11.040.10

Sector :

Medical Devices

Standard Number :

SFDA.MD/ISO 80601-2-87:2023

Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

Arabic Dcoument Price:

English Document Price:

823.50SR 194.00€

Issue Date:

2023

Scope:

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator). NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment. intended to be operated by a healthcare professional operator; intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and capable of providing more than 150 inflations/min. There are three principal designations of HFV: high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min]; high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase]. Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min. * A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.

Decument Type :

Standard

ICS :

11.040.10

Sector :

Medical Devices

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