standards-compliance

Compliance with standards

Safety and quality international standards

I am often asked to design products with compliance to standards that are relevant to them in the countries where my clients intend to sell their products. This often involves investigating and compiling the relevant standards by country. Then I apply the necessary features in the product design so that it complies with the standards and regulations.

Examples of standards I have worked with:

U.S. Toy Standard: ASTM F963
U.S. Toy Safety Standard, ASTM F963-17
U.S. Children’s Product Certificate (CPC)
U.S. Consumer Product Safety Improvement Act (2008) (CPSIA)
U.S. Reese’s Law/UL 4200A
U.S. ASTM electrical safety
U.S. FDA medical devices
U.S. FDA. 21 CFR Parts 170-199. Parts 170-199 regulations that cover food packaging
UL 94 H-B to V-0 and EN 13501 - Flammability and Fire Retardancy
U.S. FDA food contact. Regulated indirect food additives and polymers in 21 CFR 174 to 179
ISO 13485 - Quality Management Systems (QMS) and ISO 9001
IEC 60601 - Safety and essential performance of medical electrical equipment
U.K. BS 1363, 13 A plugs socket-outlets adaptors and connection units
Biocompatibility standard ISO 10993-1 and USP Class VI for toxicity.
Europe ISO 67.250 - Materials and articles in contact with foodstuffs
Europe. CE marking Safety of Toy Directive (2009/48/EC)
Europe. CE Marking Electrical equipment and the current Directive (2014/35/EU)
U.S. MIL Standards for defense equipment
UK DEF Standards for defence equipment
UK NES - Naval Engineering Standards
IEC ingress protection (IP) ratings

Here are examples of products I have designed and the most relevant standards that applied to them:

Construction toy European standards for toys safety including stability and non-use of toxic substances such as cadmium	Face shield against infection such as COVID FDA Standards for PPE - Personal Protection Equipment
iPAD for medical use UK Standards for medical equipment. Resistance to cleaning chemicals and autoclave sterilization. IP67 sealing against ingress of dust and water	Jaw exerciser FDA and ISO standards for non-use of toxic substances in the materials
Lunch box for children FDA standards for food contact in products for children	Socket adaptor UK British Standard for electrical safety in plugs socket-outlets adaptors and connection units. CE and UKAS marking. Fire retardancy to EN 13501
Bicycle safety helmet US crash protection standards. Here the helmet is being tested for compliance with such standard	Hand-held computer for the British Army Compliance with UK Defence Standards, including chemical resistance of enclosure and immersion in water to IP68. Shock, vibration and resistance to breakage when dropped on hard surfaces too.
Aid for women and children to provide urine samples Compliance with USA regulations for disposable products used in medical and law enforcement applications: bio-degradability and compostability	Network computer for Royal Navy ships Compliance with UK Naval Engineering standards including under-water explosion. The picture on the right is the unit being tested for bump compliance
Chess toy for children - click to see product Sample checking of product against the standards that it needs to comply with	Laptop computer for the British and American armies Compliance with USA MIL standards and UK Defence standards including shock, vibration, high and low temperatures, ingress of dust and water, EMC, Tempest, UV light degradation, resistance to chemicals and drop.

Compliance with standards

Safety and quality international standards

Construction toy

European standards for toys safety including stability and non-use of toxic substances such as cadmium

Face shield against infection such as COVID

FDA Standards for PPE - Personal Protection Equipment

iPAD for medical use

UK Standards for medical equipment. Resistance to cleaning chemicals and autoclave sterilization. IP67 sealing against ingress of dust and water

Jaw exerciser

FDA and ISO standards for non-use of toxic substances in the materials

Lunch box for children

FDA standards for food contact in products for children

Socket adaptor

UK British Standard for electrical safety in plugs socket-outlets adaptors and connection units. CE and UKAS marking. Fire retardancy to EN 13501

Bicycle safety helmet

US crash protection standards. Here the helmet is being tested for compliance with such standard

Hand-held computer for the British Army

Compliance with UK Defence Standards, including chemical resistance of enclosure and immersion in water to IP68. Shock, vibration and resistance to breakage when dropped on hard surfaces too.

Aid for women and children to provide urine samples

Compliance with USA regulations for disposable products used in medical and law enforcement applications: bio-degradability and compostability

Network computer for Royal Navy ships

Compliance with UK Naval Engineering standards including under-water explosion. The picture on the right is the unit being tested for bump compliance

Chess toy for children - click to see product

Sample checking of product against the standards that it needs to comply with

Laptop computer for the British and American armies

Compliance with USA MIL standards and UK Defence standards including shock, vibration, high and low temperatures, ingress of dust and water, EMC, Tempest, UV light degradation, resistance to chemicals and drop.