Global Regulatory Compliance

Thursday, December 20, 2007

Israel (Safety EMC) Regulations

This document describes the process for preparation, submittal, and certification of products by the Standards Institution of Israel (SII), based on a CB Report and Certificate with an IEC based standard with a similar harmonized standard adopted in Israel.

1. Application

1.1. Scope (Products Covered)
The scope of the certification program covers:

Electrical and electronic equipment

1.2. Type of Approval

CoC - most typical of all certifications sought in Israel

Safety Mark (not part of this discussion) – however, refer to “Summary of the procedures and conditions for the granting of a license to commodities with the Standards Mark” in the following link. More information regarding the Safety Mark can be obtained from the SII.
http://www.iecee.org/CBSCHEME/Regulatory_Requirements/israel-rr.PDF

2. Additional Instructions and References

2.1. Why a compnay needs Israel Approval?

National authorities (Ministry of Communications, Ministry of Health, Ministry of Industry and Trade) requires certain products to be certified

Certain products entering the country are held at customs and required to be certified by the SII

It is mandatory for any product type to which an existing formal Israeli Standard applies, to be tested for compliance with the particular standard. Please note that this is regardless of whether the product is regulated by the Ministry of Industry and Trade which has a listing based on HS codes. http://www.moital.gov.il/NR/rdonlyres/AC488E3E-DB52-4BA4-8C38-3BBE1440CB2D/0/tosefet_shnia.xls


The import licensing system in Israel is regulated primarily by:
a) Free Import Order of 2006 (replacing Free Import Order of 1978), Article 5(4) and Schedules 1 - 2, for purposes of citizens' security and safety, and consumers' welfare.

b) Israeli Customs Tariff and Exemptions and Tax Order of 2006, Schedule 5; for purposes of MFN tariff quota management, under the GATT.

These Orders establish the list of goods subject to import licensing. The first Order is administered by the Israeli Ministry of Industry, Trade & Labour, at the Foreign Trade Administration. The second Order is administrated by the Israeli Tax Authority at the Israeli Ministry of Finance.

Foreign Safety Marks and/or European CE mark are not acceptable. A manufacturer is entitled to mark his product with the Israeli Safety Mark, if the product complies with the applicable standard, the quality assurance of the manufacturer complies with SII procedure 005 (similar to ISO 9000) and the manufacturer’s production line is under the surveillance of SII. However, as described above, the most common route for approval is the CoC.


2.2 Technical Country Information

Rated voltage in the country 220 V/ 50 Hz single phase and 400 V/220 V, 50 Hz, 3-phase star, four wire, earthed neutral (refer to Section 4). The plug must be certified to SI-32. SI-32 Plugs and Socket Outlets, mandatory standard, is an adoption of the IEC 60884-1+ a supplement of changes to the Israeli version. One plug type is of 2 pole with earthing (Class I) ; another plug type is of 2 pole 2 wire – europlug (Class II).


2.3 Standards - Accreditation

Israeli product standards contain requirements dealing with safety, public health, or the environment and are declared by the Israeli Ministry of Industry and Trade as mandatory standards.

Every product which falls within the scope of a mandatory standard, has to comply with all the requirements of the standard in order to be marketed or used in Israel.

Most of the products where a mandatory Israeli standard applies, a Standards Institution of Israel (SII) approval is required prior to be imported into Israel. Sample(s) of the product must be delivered to SII to be evaluated for compliance with the applicable standard(s). Once approved, a sample out of every shipment has to be tested in accordance with certain clauses of the standard before approving the shipment. This step shipment inspections are typically done between the importer and the SII.

Electrical and electronic Israeli safety standards in Israel are usually adoptions of the international standards (IEC) with some national deviations.

Testing and approval must be done in Israel according to the applicable Israeli standard(s). Israel has made a large adoption of IEC standards and is also a member of the IEC CB Scheme. SII adheres to the CB scheme to the following IEC standards: IEC60065, 60950-1, IEC60601-1 and IEC 61010-1. SII accepts CB test reports and test certificates according to the CB scheme rules. While receiving these documents, only the Israeli deviations and additional unique Israel requirements are being tested/evaluated by the SII (including EMC when mandated) for the SII approval. CB test reports and test certificates are not mandatory in Israel, but can be used to reduce costs and speed up processes.

Some of the main deviations include but are not limited to the following: Hebrew warnings and instructions, Israeli plug complying with SI 32, in-country emc testing for certain categories of products, Hebrew packaging label in contrast with the package color consisting of the name of the manufacturer, the model number, country of origin and the name and address of the importer. Regarding Hebrew markings and instructions SII will help but best to involve also the Israeli importer who will also be liable for the step shipment inspections.

Some examples of the Israeli mandatory standards that manufacturers are concerned with, are SI 250 (equivalent to IEC 60065), SI 60950-1 (equivalent to IEC 60950-1), SI 1011 (equivalent to IEC 60601-1) and SI 900 (equivalent to IEC 60335-1). For complete list, refer to
http://www.moit.gov.il/NR/rdonlyres/3B119A55-718F-49C0-8B39-31B70EF53679/0/StandardsListChapter1.xls

The Israeli EMC standard is SI 961 which includes some parts, related to the relevant equipment. The parts are equivalent to the CISPR publications. The applicable parts for IT and Telecommunication equipment are equivalent to CISPR 22 and 24.

2.4 Additional Approval

Medical - http://www.ita.doc.gov/td/health/israelregs.html

Radio and Telecommunications Licensing – The Ministry of Communications (MoC) is the sole regulator; Israeli customs will not allow the import of communication devices without a written approval from the MoC. Exporters will need to work with a local agent or importer. Refer to the MoC website for a copy of the documents, http://www.moc.gov.il/ press on; 1) Organizational Structure 2) Documents for Downloading 3) Type Approval Contacts

2.5 Lead-time

Products based on a CB TR like SI-60950-1: approx. 15 working days includes emc in-country testingProducts where CB Test Reports are not accepted like SI-721 for refrigerators (based on IEC-60335-2-24 ): 60-80 working days

*Elapsed time from receipt of all necessary information.

2.6 Documentation required to begin

See below for list which is based on CB test report accepted in Israel. Where CB report/cert is not accepted, additional documentation may be required by the SII

· CB Certificates
· CB Test reports
· Application letter
· Purchase Order
· CDF
· Technical Documents (schematics, etc.).
· Component information
· Photo documentation
· Hebrew markings and instructions

2.7 Samples

Required – typically 2 samples for small samples like ITE power supplies and 1 sample for larger appliances like refrigerators

2.8 Factory Inspection

Factory inspections are not required for the CoC. Routine factory inspections by the SII only are required for products which bear the SII Mark – not part of this discussion

2.9 Marks

None for CoC. However, the customer may pursue any of the Marks offered by the SII, including the SII Safety Mark. Refer to: http://www.sii.org.il/siisite.nsf/Pages/EngMarks

2.10 Qualified testing facilities

All laboratories participating in the CB Scheme and evaluating products with Israeli harmonized and adopted standards, like SI-60950-1. Note that emc must be tested in-country.



PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
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