Glossary

Sterilization, CSSD and ECG supply terms, defined.

Short, plain-English definitions of the standards, indicator classes, packaging materials and regulatory terms that appear in CSSD work, ECG procurement and medical-device tenders in Pakistan. 30 terms, each linked to the products and guides where it matters.

Ag/AgCl electrodeAn ECG electrode whose sensor is silver coated with silver chloride, giving a stable, low-noise skin contact for recording heart signals.ANSI/AAMI EC12The ANSI/AAMI standard for disposable ECG electrodes, setting minimum electrical performance, adhesion and labelling requirements.

Biological indicatorA carrier holding a known population of highly resistant bacterial spores, used to test whether a sterilization process actually kills microorganisms.Bowie-Dick testA daily Class 2 test that checks air removal and steam penetration in a pre-vacuum steam sterilizer, run in an empty chamber before the first load.

Cardiotocography (CTG)Continuous recording of the fetal heart rate and uterine contractions during pregnancy or labour, printed as two traces on CTG paper.Certificate of conformityA document declaring that a delivered product or lot meets its stated specification and standards, usually issued per consignment or batch.Chemical indicatorA strip, tape, label or ink that changes colour when exposed to one or more conditions of a sterilization process, classified into six classes by ISO 11140-1.Class B sterilizerA small steam sterilizer defined in EN 13060 that uses fractionated pre-vacuum to remove air, so it can process wrapped, porous and hollow loads.CSSDCentral sterile services department — the hospital unit that cleans, inspects, packs, sterilizes and issues reusable medical devices.

DRAPThe Drug Regulatory Authority of Pakistan — the federal regulator for medicines and medical devices, established under the DRAP Act 2012.

Emulating indicator (Class 6)A Class 6 chemical indicator designed to react to all critical variables of one specific cycle, for example 134 °C for 3.5 minutes.EN 868-2European standard for sterilization wrap — the paper and non-woven sheets used to wrap instrument trays and packs.EN 868-5European standard for sealable pouches and reels made of porous material (paper or Tyvek®) and plastic film, used to package devices for sterilization.Establishment Licence for Import (ELI)The DRAP licence that authorises a company to import medical devices into Pakistan. ProDr’s licence number is ELI 00850.Ethylene oxide sterilizationA low-temperature gas sterilization process, typically run at about 30–54 °C, for devices that cannot tolerate steam.EU MDR 2017/745The European Union Medical Device Regulation, which sets the requirements a device must meet to carry the CE mark in the EU.

Free Sale CertificateAn official certificate from the country of manufacture confirming that a product is lawfully sold on its home market.

Heat sealingClosing a pouch or length of sterilization reel by pressing the paper or Tyvek® layer to the film with a heated sealer, forming a peelable seal.Hydrogen-peroxide gas plasma sterilizationA low-temperature sterilization process that uses vaporised hydrogen peroxide and plasma, typically at about 45–55 °C, for heat- and moisture-sensitive devices.

Integrating indicator (Class 5)A Class 5 chemical indicator that reacts to all critical variables of a steam cycle, with performance set against that of a biological indicator.ISO 11140-1International standard that sets general requirements for chemical indicators and sorts them into six classes by what they respond to.ISO 11607International standard for packaging of terminally sterilized medical devices: Part 1 covers materials and systems, Part 2 covers validation of sealing and assembly.ISO 13485International standard for quality management systems in organisations that design, manufacture, distribute or service medical devices.

Multi-variable indicator (Class 4)A Class 4 chemical indicator that reacts to two or more critical variables of a sterilization cycle, such as time and temperature.

Process indicator (Class 1)A Class 1 chemical indicator — usually indicator tape or printed ink on a pouch — that separates processed from unprocessed items.

Steam sterilizationSterilization with saturated steam under pressure — the standard method for heat-tolerant instruments, commonly at 121 °C or 134 °C.Sterile barrier systemThe minimum package that keeps microorganisms out after sterilization and lets the device be opened aseptically at the point of use, as defined in ISO 11607.

Thermal recording paperPaper coated with a heat-sensitive layer that darkens where the recorder’s thermal print head heats it — the standard medium for ECG and CTG records.Tyvek®A DuPont™ material made of flashspun high-density polyethylene fibres, used as the porous side of reels and pouches for low-temperature sterilization.

Z-fold paperRecording paper folded concertina-style into a pack, so ECG or CTG records come out as separate pages that are easy to file.

Missing a term?Ask the desk — the glossary grows with the questions buyers and CSSD teams send in.