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 Updates Medical Electrical Equipment Safety Standards
New safety requirements now apply to monitoring systems, ultrasound machines and surgical equipment.
What changed
Safety standards adopted under SI 60601 part 1 for basic safety and essential performance.
Regulatory addendum issued by the Committee on Technical Barriers to Trade clarifying requirements.
Patient monitoring systems now fall under the same regulatory framework.
Diagnostic ultrasound machines must meet mandatory safety benchmarks.
Surgical equipment is now covered by the enhanced safety requirements.
Who it affects
Importers of medical electrical equipment must ensure devices meet SI 60601 part 1 standards.
Manufacturers of patient monitoring systems must comply with new safety benchmarks.
Producers of diagnostic ultrasound machines need to align with updated requirements.
Surgical equipment suppliers must ensure products meet the new safety standards.
Compliance Update: Israel’s Enhanced Safety Requirements for Medical Electrical Equipment
Israel has updated its regulatory framework for medical electrical equipment by revising SI 60601 part 1 – Medical electrical equipment: General requirements for basic safety and essential performance. The revised standard, published in the Israel Official Gazette (Government Notices, No. 12252), entered into force on 8 February 2026 and introduces a one-year transition period during which manufacturers and importers may comply with either the old or revised standard1.
Regulation Analysis
1. Key Changes and Requirements
The revised SI 60601 part 1 aligns with international safety standards for medical electrical equipment, focusing on:
- Basic safety: Protection against electrical, mechanical, thermal, and radiation hazards1.
- Essential performance: Ensuring critical functions operate as intended under normal and fault conditions1.
- Transition flexibility: Products may be tested against either the old or revised standard until 8 February 20271.
2. Compliance Timeline
| Regulation | Key Requirement | Deadline/Threshold | Authority |
|---|---|---|---|
| SI 60601 part 1 (revised) | Mandatory compliance with updated safety and performance requirements for medical electrical equipment1. | 8 February 2026 (entry into force) | Standards Institution of Israel (SII) |
| Transition Period | Products may be tested under either the old or revised standard1. | 8 February 2027 (end of transition) | SII / Ministry of Economy |
3. Enforcement and Access to Documentation
- The final text of the revised standard is available via:
- No interpretive guidance has been issued as of the notification date1.
Summary Answer
Israel’s updated SI 60601 part 1 mandates enhanced safety and essential performance requirements for medical electrical equipment, effective 8 February 20261. A one-year transition period (until 8 February 2027) allows compliance with either the old or revised standard1. The final measure is published in the Israel Official Gazette and accessible via the Standards Institution of Israel (SII) and WTO TBT notifications1. Manufacturers must ensure their products meet the revised requirements by the transition deadline.
Sources
- ↩ 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