Product Safety

Thomas Hunter

Sr. Product Safety Test Engineer

Element Irvine

Agenda

• Introduction

• Product Safety and Product Compliance

• Principles of Safety

• Why is Product Safety Important?!

• Product Safety – Main Area of Business

• Capabilities and Certifications

• IECEE CB Scheme

• Why Element Irvine?

• Where We Are Today / Future Growth

Product Safety and Product Compliance

Product Safety, by definition, is the ability of a

product to be “safe” for intended use, as determined

when evaluated against a set of established rules.

Product Compliance, by definition, is that there is

evidence that the product meets the essential legal

requirements.

Element Product Safety Division in the US specifically

focuses on electrical products in the areas of

IT/business equipment, laboratory and measurement

equipment, medical devices and machinery.

Product Safety “Buzz” words

LVD

NRTL

Machinery

Safety

Product

Compliance

Product SafetyIECEE

Electrical

Safety

CB

Scheme

Principles of Safety

Why is Product Safety important?!

Product Safety – Main areas of business

In a nutshell..this is what we cover

Low Voltage Directive

Medical Device

Radio Equipment Directive

Machinery Safety

Directive

A50-1000Vac

or 75-

1500Vdc

One or more

moving parts

LVD limits are

removed

More or less

anything apart

from active

implantable

Product Safety - Capabilities

• Product Safety Testing – Medical Products

– Medical Electrical Equipment (IEC 60601-1)

– Specialties: Class I, Class II, Class IIA Equipment

• Product Safety Testing – Information

Technology, Audio / Video

– Information Technology/Audio/Video Equipment

(IEC 62368-1)

– Information Technology Equipment (IEC 60950-1)

• Product Safety Testing – Laboratory,

Measurement and Control Equipment

– Laboratory, Measurement and Control Equipment

(IEC 61010-1)

• Product Safety Testing – Machinery

• Machinery Directive 2006/42/EC

Safety Certification

• CB Scheme

– 52 member countries

– Covers national deviations

• NRTL Marking

– US and Canada only

– Not a regulatory requirement

– Regulated by OSHA

– Canadian rules vary

IECEE CB Scheme

• What is the IECEE CB Scheme?

– Operated by the IEC System of Conformity Assessment Schemes for Electrotechical Equipment and Components (IECEE), the IECEE CB Scheme is an international system for mutual acceptance of test reports and certificates dealing with the safety of electrical and electronic components, equipment and products.

– It is a multilateral agreement among participating countries and certification organizations, which aims to facilitate trade by promoting harmonization of national standards with International Standards and cooperation among accepted National Certification Bodies (NCBs) worldwide. By achieving this, it brings product manufacturers a step closer to the ideal concept of "one product, one test, one mark, where applicable'.

• Why is it important?

– Safety: manufacturers/suppliers must ensure that their products comply with relevant safety standards, while government regulations are generally intended to protect populations from potential risks associated with products.

– Quality: buyers/wholesalers want to ensure the quality of products purchased and unhindered market access. Interoperability: product manufacturers and end users want to be sure their products work and can interact with other products, services and installations.

– Consistency: manufacturers/suppliers want to be sure their marketed products comply with the sample assessed.

IECEE CB Scheme (cont.)

• Who benefits from it?

– Governments: are able to reduce trade barriers caused by different certification criteria of countries. Countries can better meet their obligations as stated in the World Trade Organization’s Agreement on Technical Barriers to Trade.

– Industry: can reduce delays and costs of multiple testing since a product can be certified once by a single National Certification Body (NCB) which can be accepted by others worldwide, usually without the need for further product assessment. Markets can be expanded and product to market time reduced.

– End users: ultimately anyone using a product which has been tested and certified using the IECEE CB Scheme has the assurance that the goods purchased will perform to expectations and are reasonably safe when used as intended.

For More Info: https://www.iec.ch/about/brochures/pdf/conformity_assessment/IECEE_brochure_LR.pdf

IEC 62368 / 60950 / 61010 Testing

Medical Product Safety Testing

Off-Site Machinery Evaluation and Test

Why Element Irvine?

Element Irvine

Prime Location

Growing medical industry

Client base

Space availability

Recruitment

Product Safety Irvine: Where We Are Today (4/2019)

Product Safety Lab Operational (1/2018)

Marketing activities on-going

NVLAP Accreditation in place and work is commencing

IECEE CB Scheme in place and work is commencing

Machinery Product Safety, IEC 60204-1, added to capabilities

Recruitment has begun to add additional staff

Stay tuned. More to come in 2019!!

Thank you for attending

our Seminar today!