Product Standards For Medical Devices

Product Standards For Medical Devices

In the Indian Medical Device Registration (IMDR) structure, adherence to item principles rules is a fundamental need for ensuring the security, suitability, and nature of clinical devices open in the Indian market. Product standards go about as benchmarks for producers and vendors, guiding them in the arrangement, creation, and dissemination of clinical contraptions that meet spread-out rules for execution and security.

Product Standards for Medical Devices?

The Product standards for Medical devices consist of a lot of rules and rules spread out to ensure these devices’ prosperity, quality, and practicality. They cover everything from planning and assembling cycles to naming and bundling necessities.

Why are Product Standards Important?

The Product Standards of medical device rules are major for protecting the wealth and success of patients. By adhering to these rules, creators can restrict the bet of wickedness connected with the usage of clinical contraptions. For purchasers, item guidelines confirm that the gadgets they depend on meet specific quality and well-being rules.

Do product Standards for Medical Devices Impact Manufacturers?

Manufacturer registration of medical devices ought to agree with the standards established by authoritative bodies like the FDA License (Food and Drug Association) in the US or the CE looking at requirements. The failure to fulfill these rules can achieve authoritative approvals, thing audits, and mischief to the association’s standing.

What are Product Standards for Medical Devices?

The Product standards for medical devices are a set of rules and rules spread out to ensure these devices’ quality, and reasonability. They cover all that from arranging and gathering cycles to stamping and packaging requirements.

For more information like Medical device labeling, you check this.

What are the Types of Product Standards for Medical Devices?

There are many types of product standards for medical devices, check out below:-

Technical specification –  These standards define technical requirements and specifications for the design, construction, and performance of medical devices. Examples include standards for materials, dimensions, and operating characteristics.

Quality Management System – QMS standards, let’s say, ISO 13485, describes the requirements for spreading out and staying aware of value organization structures expressly uniquely designed for the gathering of medical devices.

Risk Management – Norms that are connected with risk the board, for instance, ISO 14971, give guidelines for recognizing, evaluating, and relieving gambles related to the utilization of clinical gadgets.

Marking and Guidelines for Use – Principles administering naming and guidelines for use guarantee that clinical gadget marking gives clear and precise data to clients concerning gadget distinguishing proof, signs for use, admonitions, and safety measures.

Compliance With Product Standards of Medical Standards

  1. Managing Assessment – Evaluating the clinical gadget against important item guidelines to distinguish any holes in consistency.
  2. Documentation – Incorporating documentation, including specialized details, test reports, and quality administration framework documentation, to exhibit similarity with item norms.
  3. Testing – Leading testing and assessment exercises, as expected side-effect guidelines, to check the wellbeing, adequacy, and execution of the clinical gadget.

Various Standards Applicable on Medical Devices

Here are a few product standards that apply to medical devices:-

S.NoProduct StandardsDescriptionBIS ItemBIS No.
1.IS 13485Quality Management System for Medical DevicesQMS DocumentationIS 13485:2016
2.IS 16073Medical devices — QMS — Needs for regulatory purposesQuality Management System DocumentationIS 16073:2018
3.IS 14971Application of risk management to medical devicesRisk Management DocumentationIS 14971:2019
4.IS 7620Medical electrical equipment — specific needs for the safety of infusion pumps and controllersTechnical SpecificationsIS 7620:2016
5.IS 10254Medical infusion pumps — Safety requirements and test methodsTechnical SpecificationsIS 10254:2021
6.IS 13450Medical devices — Validation and routine control of sterilization processes employing moist heatTechnical SpecificationsIS 13450:1991
7.IS 60601 seriesMedical electrical equipment standardsTechnical SpecificationsTechnical Specifications
8.IS 10651 seriesNon-invasive sphygmomanometers — Particular conditions and methods of measurementTechnical SpecificationsVaries (e.g., IS 10651-1:1993)
9.IS 13456Medical devices — Only-use sterilized surgical suture needles — Necessities and test methodsTechnical SpecificationsIS 13456:2016
10.IS 13584Medical devices — Biological evaluation of medical devicesTechnical SpecificationsIS 13584:1994
11.IS 13943Medical devices — General requirements for safetyTechnical SpecificationsIS 13943:1994
12.IS 15223 seriesMedical devices — symbols to be utilized with clinical gadget names, marking, and data to be providedLabeling and Instructions for UseVaries (e.g., IS 15223-1:2016)
13.IS 15800 seriesMedical devices — Sanitation of health care products — Requirements for validation and routine control — Industrial moist heat sterilizationManufacturing Process DocumentationVaries (e.g., IS 15800-1:2012)
14.IS 16000 seriesMedical devices — Quality management and comparing general views of clinical gadgetsQuality Management System DocumentationVaries (e.g., IS 16000-6:2019)
15.IS 16861Medical devices — Application of risk management to medical devicesRisk Management DocumentationIS 16861:2018
16.IS 17025General requirements for the competence of testing and calibration laboratoriesTesting ProtocolsIS/ISO/IEC 17025:2017
17.IS 17822 seriesMedical devices — QMS — Requirements for regulatory purposesQuality Management System DocumentationVaries (e.g., IS 17822-1:2020)
18.IS 18382Medical devices — QMS — Guidance on the application of ISO 13485Quality Management System DocumentationIS 18382:2016
19.IS 2052Metal-cutting machine tools — Test conditions for testing the exactness of exhausting and processing machines with even spindle — Part 2: Machines with movable columns along the horizontal axisTesting ProtocolsIS 2052:1992
20.IS 9000 seriesQuality management and quality assurance standardsQuality Management System DocumentationVaries (e.g., IS 9000-5-2:1991)


All in all, Following rules or product standards for medical devices is fundamental for guaranteeing the well-being and nature of the medical device in the IMDR framework. These rules guide manufacturers in gathering execution models and limiting dangers. As innovation develops, consistency with these principles stays crucial for keeping up with viability and security in medical care.


Can International Standards Fulfill Indian Requirements?

Yes, however, extra documentation might be needed to address clear Indian guidelines.

Are There Some Notified Agencies in Compliance?

Yes, They survey consistency and issue certification for medical devices.


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