Name That Standard
This is the standard series for electrical and functional safety
What is IEC 60601
ISO
What is the International Standards Organization?
The ethical hacking of a device.
What is "pen" testing?
The current SPS for cybersecurity
Who is Jan Küfner?
(But changing to Paul Picchione later this year!)
The series of standards for biocompatibility
What is ISO 10993?
MRI
What is Magnetic Resonance Imaging
Test method to check cell viability after exposure to a device extract. (Hint: one of the UAA test methods)
What is cytotoxicity?
The lab manager of the New Brighton BRL lab.
Who is Nicole Cufaude?
The standards for packaging assessments and validations.
What is the ISO 11607 series?
EMC
What is Electromagnetic Compatibility?
The validation that there are not contaminants left on the device after following the manufacturer's instructions.
What is a cleaning validation?
The Americas sales director for MHS. (Hint: If you have client interested in testing this is who you send it to)
Who is John Lanzafame?
The standards for biocompatibility of breathing gas pathway devices.
What is ISO 18562?
CPP
What is a control system + two protective systems in functional safety?
Evaluates whether current that flows between an AC source and the ground does not exceed a specified limit
Leakage current test
Point of contact for functional safety testing
Who is Thomas Betzl?
Series of standards for sterility of a medical device.
What is ISO 11737?
BRL
What is BioSafety, Reprocessing, Lot Release Testing?
The two types of aging required in a packaging validation.
What is real-time and accelerated aging?
Lab manager of MRI safety testing
Who is Krishna Singhal?