Israel Updates Medical Electrical Equipment Safety Standards

Israel has updated its regulatory framework for medical electrical equipment through the implementation of enhanced safety requirements under SI 60601 part 1 and an official addendum to its technical barriers policy.

Israel has updated its mandatory safety standards for medical electrical equipment, aligning them with enhanced requirements under SI 60601 part 1, effective Feb. 8. The measure applies to all medical devices powered by electricity or batteries sold in the country.

The revised standard, published in the Israel Official Gazette as SI 60601 part 1, sets general requirements for basic safety and essential performance of medical electrical equipment. It replaces the previous version and was notified to the World Trade Organization on Feb. 11 in an addendum to notification G/TBT/N/ISR/1293/Rev.1.

Manufacturers, importers and distributors of medical electrical equipment, including diagnostic imaging systems, patient monitors and surgical devices, are subject to the new rules. The standard covers products ranging from large hospital equipment to portable devices used in home care settings.

The notification said the revised standard entered into force on Feb. 8, the same date it was published in the official gazette. A one-year transition period allows products to be tested under either the old or new standard until Feb. 8, 2027.

Medical electrical equipment must now meet updated safety and performance criteria, including electrical insulation, mechanical stability and risk management processes. The standard incorporates international best practices for mitigating hazards such as electric shock, fire and electromagnetic interference.

The Israel Standards Institute, which administers the mandatory standard, provides the full text of the measure on its website. The notification said the document is also available through the WTO’s Technical Barriers to Trade portal.

Products certified under the previous version of SI 60601 part 1 remain valid during the transition period. After Feb. 8, 2027, all new and existing medical electrical equipment must comply with the revised standard to be marketed in Israel.

The standard applies to both domestically manufactured and imported medical devices. It does not distinguish between products based on country of origin, applying uniformly to all equipment entering the Israeli market.

Medical electrical equipment covered by the standard includes devices such as defibrillators, infusion pumps, ventilators and electrocardiographs. The scope extends to accessories and software that are integral to the operation of such equipment.

The notification said the measure was adopted without a public comment period. The WTO addendum indicated no changes were made to the notified measure after its initial circulation.

Compliance with the standard is verified through testing conducted by accredited laboratories. The Israel Standards Institute oversees the certification process and maintains a list of approved testing facilities.

The standard does not introduce new labeling requirements but reinforces existing rules on marking and instructions for use. Manufacturers must ensure that product documentation clearly describes safety features and operational limits.

Medical electrical equipment that fails to meet the standard’s requirements may be denied entry into Israel or subject to recall. The notification did not specify penalties for non-compliance but referred to existing enforcement mechanisms under Israeli law.

The revised standard aligns with international standards, including those developed by the International Electrotechnical Commission. The notification said the update reflects advances in technology and evolving safety expectations in medical device regulation.

The transition period allows manufacturers time to update production processes and obtain new certifications. The notification said no extensions to the Feb. 8, 2027 deadline are anticipated.

The standard applies to all medical electrical equipment, regardless of whether it is intended for professional or home use. It excludes devices that do not rely on electrical power, such as manual surgical instruments or non-powered diagnostic tools.

The notification said the measure was developed in consultation with industry stakeholders, though no formal public consultation was held. The Israel Standards Institute coordinated the revision process with input from medical professionals and regulatory bodies.

The standard’s requirements are mandatory for all medical electrical equipment sold in Israel, including products intended for clinical trials or temporary use. The notification did not provide exemptions for specific categories of devices.

The Israel Standards Institute said the revised standard aims to reduce risks associated with medical electrical equipment. The notification did not quantify expected improvements in safety outcomes or reductions in adverse incidents.

The standard’s implementation does not affect existing trade agreements or preferential tariff arrangements. Medical electrical equipment remains subject to Israel’s general import regulations, including customs duties and documentation requirements.

The notification said the measure was notified to the WTO under the Agreement on Technical Barriers to Trade. The addendum confirmed that the standard does not create unnecessary obstacles to international trade.

The standard’s requirements apply to both new and refurbished medical electrical equipment. The notification did not address whether the rules extend to devices imported for personal use or donated to healthcare facilities.

The Israel Standards Institute provides guidance on interpreting the standard’s provisions. The notification said no additional interpretive documents have been issued but may be released if needed.

The standard’s adoption follows a review of Israel’s regulatory framework for medical devices. The notification did not indicate whether further revisions to related standards are planned.

The transition period allows importers to clear existing inventory under the old standard. After Feb. 8, 2027, all medical electrical equipment must meet the new requirements to be sold in Israel.

The notification said the standard’s text is available in Hebrew and English. The Israel Standards Institute’s website provides access to both versions, along with supporting documentation.

The measure does not introduce new fees for certification or testing. The notification said existing fee structures for compliance assessments remain unchanged.

The standard’s requirements are enforceable through Israel’s existing regulatory framework for medical devices. The notification did not specify whether additional enforcement resources have been allocated.

The next review of the standard is not scheduled. The notification said the Israel Standards Institute will monitor implementation and may propose updates if necessary.

The standard’s adoption does not affect Israel’s participation in international mutual recognition agreements for medical device certification. The notification said existing arrangements remain in place.

The measure applies to all medical electrical equipment, including devices used in veterinary medicine. The notification did not distinguish between human and animal health applications.

The transition period ends on Feb. 8, 2027. After that date, only products certified under the revised standard will be permitted for sale in Israel.

Sources

1. Committee on Technical Barriers to Trade – Notification – Israel – Medical electrical equipment – Addendum https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN23/ISR1293R1A1.pdf&Open=True