Reports

Standards:

Since breast pumps are defined as medical devices in some countries, we evaluate the technical requirements of our spare parts against EU's IEC 60601-1:2005 and US's UL standards for their intended uses.  We also verify our spare parts with UK MHRA's Guidances on Medical Devices, EU's Medical Device Directives 93/42/EC and US FDA's requirements on class I of medical devices for the intended use.   For those parts can also be regarded as the regular daily utensil, No. 10/2011 is applied. All of our parts are tested to show containing no BPA.  The results show that our products are safe, significantly equivalent and effective as spare parts for intended medical devices.

Equivalence Tests:

As part of the regulatory requirements,  we perform Equivalence Tests on each replacement part we develop.  We validate our products with the intended breast pumps as a complete system.  We also have user feedbacks collected after trial uses of our products.  Our parts are shown to be significantly equivalent to the OEM parts before we put them on the market.

US FDA Inspection:

Our products are listed with US FDA as class II medical devices (Dev. No. D192499).  Due to this fact, USA inspects Maymom's facility in Sept. 2014.  Maymom is in full compliance with USA FDA laws.  No major observations are found and Maymom is authorized to continue to operate its business in USA.

Reports:

Although the tubing will not come in contact with the breastmilk, we don't just ignore the safety of it.  Each batch of our product is tested by independent SGS SA or InterTek labs, for safety.  They are tested against EEC Directive on Overall Migration Test of Plastic Material and Articles Intended to Come into Contact with Food stuffs, No. 10/2011.  

Membranes and duckbill valves are tested against USA FDA's standards for material as food container and food packaging material (21 CFR 177.2600)

Valves and breastshields (flanges) are tested against USA FDA's standards for material as food container and food packaging material (21 CFR 177.1520) and EU Total migration and BPA migration tests.

AC adapters are tested against USA UL standards and Canadian cUL for electronics to be used indoors (81GJ E135856)

Car charger components are tested against USA UL standards and Canadian cUL.  Multiple safety features are built-in to protect the connected breast pumps. 

Five  years of safety test reports are shown below.  Our products are safe to use around moms and babies!