Physical Testing

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment — IS 13450: Part 2: Sec 27 (2018) Testing

IS 13450: Part 2: Sec 27 (2018) is a BIS product testing standard for medical devices & textiles (1 notified product). Book laboratory testing required for ISI Mark / CRS certification.

IS · India

IS (Indian Standards) — typically accepted in India. Bureau of Indian Standards test methods — primary evidence for BIS / India market compliance and many domestic buyer specs.

Product category: Medical Devices & Textiles
Main standard: IS 13450: Part 2: Sec 27 (2018)
Test type: Physical
Accreditation: ISO/IEC 17025 / NABL (BIS-recognised labs)
Testing timeline: 7–14 working days
Sample size required: Specimen set as per standard (lab-confirmed)
Tentative testing price: ₹3L – ₹12.1L

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IS 13450: Part 2: Sec 27 (2018) laboratory testing

IS 13450: Part 2: Sec 27 (2018) is a BIS certification testing standard. Products notified under this IS must be tested in recognised laboratories before ISI Mark / CRS registration can proceed.

Discipline

Mapped under Physical Testing based on the typical product family (Medical Devices & Textiles).

What labs typically evaluate

Conformance to the clauses in IS 13450: Part 2: Sec 27 (2018)
Safety / performance / material checks required for the notified product
Report pack suitable for BIS application and surveillance

BIS products covered by this standard

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment (ISI)

Next step

Share your product datasheet / HSN and target scheme (ISI or CRS). Certko maps the lab scope, indicative cost and booking path.

BIS products tested to this standard

7 BIS-notified products map to IS 13450: Part 2: Sec 27 (2018) — open a product for scheme, labs and indicative costs.

ISI Mark · Medical Devices & Textiles

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 20 Infant Transport Incubators First Revision

IS 13450: Part 2: Sec 20 (2023)

ISI Mark · Medical Devices & Textiles

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs

IS 13450: Part 2: Sec 25 (2018)

ISI Mark · Medical Devices & Textiles

Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision

IS 13450: Part 2: Sec 2 (2024)

ISI Mark · Medical Devices & Textiles

Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs

IS 13450: Part 2: Sec 26 (2021)

ISI Mark · Medical Devices & Textiles

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer

IS 13450: Part 2: Sec 21 (2018)

ISI Mark · Medical Devices & Textiles

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment

IS 13450: Part 2: Sec 27 (2018)

ISI Mark · Medical Devices & Textiles

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision

IS 13450: Part 2: Sec 21 (2023)

FAQs about Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment — IS 13450: Part 2: Sec 27 (2018) Testing

What does “Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment — IS 13450: Part 2: Sec 27 (2018) Testing” cover?

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment — IS 13450: Part 2: Sec 27 (2018) Testing covers the key parameters for this product/test type under IS 13450: Part 2: Sec 27 (2018). Review the writeup on this page for scope details, then request a quote for your exact sample.

Which accreditation applies?

This scope is typically run in ISO/IEC 17025 / NABL (BIS-recognised labs) accredited laboratories. Confirm the exact lab and NABL scope on your quotation.

How do I get a quote for this test?

Use Get Expert Help / Contact with your product name, target market and any buyer specification. We map the lab, sample size and indicative turnaround.

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