Services
Areas of Compliance
We understand the many layers of compliance that your product needs to meet. We endeavor to maximize the overlap between the various areas of compliance to reduce time on the tool and in the long run cost.
We understand the many layers of compliance that your product needs to meet. We endeavor to maximize the overlap between the various areas of compliance to reduce time on the tool and in the long run cost.
SEMI S2 Evaluation Details
SEMI S2 is a safety guideline developed by Semiconductor Equipment and Materials International (SEMI®). SEMI S2 is a comprehensive umbrella safety guideline targeted at semiconductor manufacturing equipment but has been used in emerging industries such as flat panel display and solar panels. The first version of SEMI S2 was published in 1991 and has been updated several times since them. Receive up-to-date information of the most current SEMI versions by signing up for the SEMI Newsletter.
Design Review to include:
- A preliminary design evaluation of the equipment to all applicable sections of SEMI S2 and the specific SEMI Guidelines referenced (S1, S3, S8, S14, and S22) and/or to applicable USA or European standards upon request
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
- An electronic copy of Design Review Report issued within 14 working days following the on-site evaluation
Comprehensive Evaluation to include:
- A comprehensive evaluation of the equipment to all applicable sections of SEMI S2 and the specific SEMI Guidelines referenced (S1, S3, S8, S14, and S22)
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
- An electronic copy of Interim Report issued within 14 working days following the on-site evaluation
- An electronic copy of Final Evaluation Report issued within 14 working days of receipt of satisfactory responses to the discrepancies identified in the Interim Report
US Regulatory Evaluations Detail
Field Evaluation to include the following:
- A comprehensive evaluation of the equipment utilizing the appropriate national and product safety standards (e.g., NFPA 79)
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
- An electronic copy of Bullet List Discrepancy Report issued within 3 working days following the On-Site evaluation
- An electronic copy Final Report issued within 7 working days following receipt of satisfactory responses to the Bullet List Discrepancy Report
- A Field Evaluation sticker issued for the equipment having a satisfactory evaluation or reevaluation
- An approval letter issued to the local Authority Having Jurisdiction (AHJ) issued within 3 working days following the Field Evaluation sticker for the equipment having a satisfactory evaluation or re-evaluation
CE Marking Evaluation Details & Options
During the development of the European Union, EU authorities developed an approach to facilitate the import of goods into the member states from other members states and the rest of the world. The EU authoritie developed directives issued under Article 100b of the EEC treaty. The purpose of the directives is to set binding requirements for trade goods throughout the EU focusing on product safety. These requirements are deemed "essential requirements" for all goods bought & sold in the EU. The manufacturer shows that the product conforms to the requirements of the Community directive by placing a CE mark on the product. The CE mark shows that the manufacturer declares his product to comply with all relevant directives (sometime referred to as "self-declaration").
ESTEC Solutions' evaluators are able to offer a variety of options to a manufacturer for CE Marking of their products. Two of the more common Safety Directives and ESTEC's Approaches to conformance are outlined below.
Low Voltage Directive CE Marking evaluation to include the following:
- A comprehensive evaluation of the equipment to the Low Voltage Directive utilizing harmonized standard EN 60204-1 or EN 61010, as appropriate
- An informal Mechanical evaluation utilizing Annex I of the Machinery Directive
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
- An electronic copy of Bullet List Discrepancy Report issued within 3 working days following the On-site evaluation
- An electronic copy of Final Evaluation Report issued within 14 working days following receipt of satisfactory responses to the Bullet List Discrepancy Report
Machinery Directive CE Marking evaluation to include the following:
- A comprehensive evaluation of the equipment to the Machinery Directive utilizing harmonized standard EN 60204-1 or EN 61010, as appropriate
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy isues at the end of the on-site evaluation
- An electronic copy of Bullet List Discrepancy Report issued within 3 working days following the On-site evaluation
- An electronic copy of Final Evaluation Report issued within 14 working days following receipt of satisfactory responses to the Bullet List Discrepancy Report
Laser Evaluation Details
EN 60825-1 Laser Evaluation
- A comprehensive evaluation of the equipment and its embedded laser systems to the requirements in EN 60825-1
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
- An electronic copy of Final EN 60825-1 Laser Report issued within 14 working days following the On-site evaluation. Report will be included as part of the Machinery Directive CE Marking evaluation report.
FDA-CDRH Laser Evaluation and Laser Product Report
- A comprehensive evaluation of the equipment and its embedded laser systems to the requirements in FDA-CDRH Subpart J
- Internal Technical Peer Review
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation
An electronic copy of FDA-CDRH Laser Product Report issued within 14 working days following the on-site evaluation. Report will be prepared for the client to be included as the submittal package to the FDA-CDRH and used as conformance to the SEMI S2 laser requirements.
Industrial Hygiene Testing and Evaluation Details
Industrial Hygiene Testing to include the following (when performed separately from a SEMI S2 evaluation):
- Preparation of Test Plan prior to physical testing submitted to client for approval
- Use of appropriate and calibrated direct reading or integrated test equipment and method for the specific agent to be tested
- Internal Technical Peer Review
- An electronic copy of Industrial Hygiene Survey Report issued within 14 working days of on-site testing. Report will be suitable as a stand-alone report or for inclusion within existing or future SEMI S2 evaluation report
Exhaust Ventilation Testing (SEMI S6 Tracer Gas Testing) to include the following:
- Preparation of Test Plan prior to physical testing for each specified exhausted enclosure to conform to SEMI S6 Guidelines for internal flammability and/or external toxicity
- Use of appropriate and calibrated test equipment and method
- Internal Technical Peer Review
- An electronic copy of SEMI S6 Exhaust Ventilation Report issued within 14 working days of nn-site testing. Report will be suitable as a stand-alone report or for inclusion within existing or future SEMI S2 evaluation report
Design for Safety Training Details
Design for Equipment Safety Training to include the following:
- Preparation and Presentation to all applicable or specifically requested industry, US, or European guidelines or standards to assist in equipment design to ensure conformance
- General requirements as they apply to Client's specific equipment
- Practical examples for conforming to specific requirements
- ESTEC Solutions will provide electronic copies of training materials